## Attachment: Formatting for Standard Cancer Center Summaries

Interim Revision

June 2006

Standard Cancer Center Information Summaries ensure consistency and
thoroughness of peer review of competing applications and also are used
to produce summary reports on the Cancer Centers Program.

**Submit the following summaries by application type:**

[Code]{.underline} [Type of Application]{.underline} [Submit
Summaries]{.underline}

Type 1 or 1A New Competing or Amended 1, 2, 3, and 4

Type 2 or 2A Competing Renewal or Amended 1, 2, 3, 4, and 5

Type 3 Administrative Extension with Funds Consult Program Director

Type 5 Non-competing Continuation 1, 2, 3, and 4

***Centers must also submit an electronic copy of their summary
information, in a format compatible with the Cancer Centers Branch
database, directly to the Cancer Centers Branch** **at the time the
application is submitted.*** Send summary information as an attachment
to the email address below:

> <ccsgdata@mail.nih.gov>

**General Instructions for Summaries:**

-   Insert the full grant number (e.g., 1P30CA000000-01) in the upper
    right corner of *each* page.

-   Label summaries consistently (e.g., 1A, 1B, 1C).

-   Provide *only* the information requested.

-   Follow the example formats provided.

#### Summaries 1A, 1B, 1C, and 1D

## Cancer Center Senior Leaders, Research Programs, Program Members, and Shared Resources as of the Reporting Date Indicated on the Summary

**Summary 1A:** List the names, titles, and academic degree(s) of the
senior leadership of the Center (e.g., Cancer Center Director, Deputy
Director, Associate Directors, etc.). Indicate a change in leadership
with an asterisk next to the new leader's name.

**Summary 1B**: List the name of each Program, the name and academic
degree(s) of the Program Leader, and the number of members in the
program. Indicate a change in leadership by an asterisk next to the new
leader's name. Assign a unique reference code (e.g., 01, 02, or GYN, GU,
etc.) to each program in this table (for use in Summaries 2 and 4). Do
not list developing programs. Use the code (ZY) for non-programmatically
aligned members. Use this code also to identify projects (Summary 2) and
trials (Summary 4) conducted by non-aligned center members. *Do not list
individual program members*.

**Summary 1C:** Provide the total number of programmatically aligned and
non-programmatically aligned members, and the total of all center
members.

**Summary 1D:** List the full name of each shared resource of the cancer
center, and the name and academic degree(s) of the resource director.
Select up to three category codes for each shared resource from the list
entitled "Categories of Shared Resources." Include *only* shared
resources proposed for support by the CCSG. A listing of developmental
cores supported with CCSG funds is optional, but useful for
informational purposes. Developmental cores should be clearly identified
as such if included.

**Categories of Shared Resources:** To each shared resource, assign the
appropriate 3-digit numbers (maximum of three category codes) to
indicate the applicable categories and subcategories.

+----------------------------------+-----------------------------------+
| ##                               |                                   |
| # Category 1: Laboratory Science |                                   |
+----------------------------------+-----------------------------------+
| 1.01 Biochemical Analysis        | 1.19 Cyclotron or Radiolabeling   |
|                                  |                                   |
| 1.02 General Animal Facility     | 1.20 Molecular Biology            |
|                                  |                                   |
| 1.03 Transgenic Facility         | 1.21 Nucleotide Sequencing        |
|                                  |                                   |
| 1.04 Special Breeding            | 1.22 Protein & Peptide Sequencing |
|                                  |                                   |
| 1.05 Animal Health               | 1.23 Monoclonal Antibodies        |
| (Pathology/Histology)            |                                   |
|                                  | 1.24 NMR                          |
| 1.06 Animal Health (QC)          |                                   |
|                                  | 1.26 MRI                          |
| 1.08 Specific Pathogen Free      |                                   |
| (Barrier Animal Facility)        | 1.27 Spectrometry, Other          |
|                                  | (Specify)                         |
| 1.09 Nude Mouse                  |                                   |
|                                  | 1.28 Radiobiology                 |
| 1.10 Specialized Animal Svcs     |                                   |
| (Irradiation)                    | 1.29 Oligonucleotide Synthesis    |
|                                  |                                   |
| 1.11 Biohazard Control           | 1.30 Protein/Peptide Synthesis    |
|                                  |                                   |
| 1.12 Organic & Synthetic         | 1.31 Toxicology/Mutagenesis       |
| Chemistry                        | Testing                           |
|                                  |                                   |
| 1.13 Chromatography              | 1.33 Confocal Microscopy          |
|                                  |                                   |
| 1.14 Cytology-Analytic &         | 1.34 Xray Diffraction             |
| Immunologic                      |                                   |
|                                  | 1.35 DNA Array                    |
| 1.15 Cytogenetics                |                                   |
|                                  | 1.36 Proteomics                   |
| 1.16 Genetics                    |                                   |
|                                  | 1.37 Other (Define)               |
| 1.17 Electron Microscopy         |                                   |
|                                  |                                   |
| 1.18 Flow Cytometry              |                                   |
+----------------------------------+-----------------------------------+
| ##                               |                                   |
| # Category 2: Laboratory Support |                                   |
+----------------------------------+-----------------------------------+
| 2.01 General or Equipment Repair | 2.04                              |
|                                  | Illustration/Photography/Typeset  |
| # 2.02 Machine Shop              |                                   |
|                                  | 2.07 Tissue Culture               |
| 2.03 Glassware Washing           |                                   |
|                                  | 2.08 Media Preparation            |
|                                  |                                   |
|                                  | 2.10 Other (Define)               |
+----------------------------------+-----------------------------------+
| ### Category                     |                                   |
|  3: Epidemiology, Cancer Control |                                   |
+----------------------------------+-----------------------------------+
| 3.01 Cancer Control              | 3.05 Nutrition                    |
|                                  |                                   |
| 3.03 Epidemiology                | 3.06 Other (Define)               |
|                                  |                                   |
| 3.04 Survey                      |                                   |
+----------------------------------+-----------------------------------+
| #                                |                                   |
| ## Category 4: Clinical Research |                                   |
+----------------------------------+-----------------------------------+
| 4.02 Clinical Trials Protocol    | 4.05 Pharmacology (Lab Tests)     |
| Management & Data Management     |                                   |
|                                  | 4.06 Human Tissue Acquisition &   |
| 4.03 Clinical -- Other           | Pathology/Histology               |
|                                  |                                   |
| 4.04 Pharmacology (Animal)       | 4.07 Gene Therapy/Vector          |
|                                  |                                   |
|                                  | 4.08 Other (Define)               |
+----------------------------------+-----------------------------------+
| **Category 5: Administrative**   |                                   |
+----------------------------------+-----------------------------------+
| 5.01 Secretarial/Word Processing |                                   |
+----------------------------------+-----------------------------------+
| **Category 6: Biostatistics**    |                                   |
+----------------------------------+-----------------------------------+
| 6.01 Biostatistics               |                                   |
+----------------------------------+-----------------------------------+
| **Category 7: Informatics**      |                                   |
+----------------------------------+-----------------------------------+
| 7.01 Clinical Research           | 7.03 Public Health/Epidemiology   |
| Informatics                      | Informatics                       |
|                                  |                                   |
| 7.02 Bioinformatics              | 7.04 Other (Define)               |
+----------------------------------+-----------------------------------+
| **Category 8: Miscellaneous**    |                                   |
+----------------------------------+-----------------------------------+
| 8.01 (Define)                    |                                   |
+----------------------------------+-----------------------------------+

Example Format 2P30CA654321-50

##### Outstanding University Cancer Center

Reporting Date: mm/dd/yyyy

#### Summary 1A - Senior Leadership

**Name of Senior Leader Title of Leader Degree(s)**

Sutton, Baylor D. Principal Investigator M.D., Ph.D.

Marucco, Gina L. Deputy Director Ph.D.

Galley, Mark E. Assoc. Director for Basic Science M.D.

Barrie, Thomas X. Assoc. Director for Clinical Research M.D., Ph.D.

Wong, Lee R. Assoc. Director for Population Research Ph.D.

Young, Jenni Jo Assoc. Director for Administration MHA

#### Summary 1B - Programs, Leaders, and Codes

**Program Total \# Members**

**Code\* Program Name Program Leader(s) (including leader)**

01 Molecular and Cellular Biology Harrington, Marc, M.D, Ph.D. 25

02 Cancer Control and Prevention Pham, Phuong T. K., Ph.D. 14

03 Epidemiology Kaufman, Richard, M.D., Ph.D. 19

04 Developmental Therapeutics Wood, Mary, M.D., Ph.D. 15

05 Women's Cancers Miller, Barbara, Ph.D 22

CCGC Cell Cycle and Growth Control Neuhauser, Beverly N., M.D. 12

IM Immunology \*Bhorjee, Jaswant, M.D., Ph.D. 27

ZY Non-Aligned Members 12

\* Centers may use any coding scheme they wish.

#### Summary 1C: Cancer Center Membership

**Type of Member Total Number**

Programmatically Aligned Members (Individuals) 134

Non-Programmatically Aligned Members (Individuals) 12

Grand Total - Total Number of Center Members (Individuals) 146

#### Summary 1D: Shared Resources

**Name of Shared Resource Resource Director(s) Category**

Biostatistics Francini, Benjamin, Ph.D. 6.01

DNA Microarray (developing) Poole, Bruce D., M.D. 1.35

DNA Sequencing Kelley, Steven, S., M.D., Ph.D. 1.22

Genomics and Proteomics Goldstein, Phillip, M.D. 1.36

Bioinformatics Mayrend, Jody, Ph.D. 7.02

Organic Synthesis Singer, Richard, F., M.D., Ph.D. 1.12

Transgenic Animal Facility Peterson, Douglas, M.D. / Barns, Nancy, M.D.
1.03, 1.06, 1.09

**Summary 2A: Active Funded Projects as of the Reporting Date Indicated
on the Summary**

List all active funded, cancer-relevant projects competitively awarded
by external sources to the fiscally responsible institution of which the
cancer center is a part. If more than one institution is an integral
part of the cancer center, provide a Summary 2A for each institution.
Separate the list of grants in alphabetical order by Principal
Investigator's last name into two parts:

-   active funded research projects

-   training and career development grants

In Summary 2A, do not sort or group grants by research Program or
funding agency. (Note: A list of the externally funded projects by
Program is requested for competing renewal applications as part of the
programmatic description. See Section 8.0, Research Programs.)

For each project, list the Principal Investigator (PI); funding source
(e.g., NCI, NIAID); complete project number with prefix and suffix
showing the current grant year (e.g., 5R01 CA012345-06,
2N01CA654321-12); full project period (e.g., 3 yr:1/1/05-12/31/07 etc.)
and the full project title.

Identify the CCSG approved research program(s) to which each project
belongs in the "prog code" column using the codes from Summary 1B. For
individual projects split among two or more research programs, list the
grant in separate records for each program code to which the project is
assignable, with the code in the "prog code" column, and the proportion
attributable to the program in the "%" column. List once, in the first
record only, the total direct costs of the grant in the "Direct Cost"
column and the total costs (direct plus indirect) in the "Total Cost"
column. For the last two columns, and for each record, calculate the
proportional amounts of direct and total costs attributable to the
program. The *Dubois, Y.* grant in the example format demonstrates how
to document a split project. For national trials coordinated by your
center, indicate only the direct and total costs for work performed at
your center.

The sum of the percentages and dollars of any project assigned to
different programs should not exceed 100%. However, if only part of a
project is carried out within the cancer center, only the cancer center
portion should be shown; the total percentage for such a project will be
less than 100%.

Use the non-programmatically aligned code (ZY) to list any funded
research projects or parts of projects not assigned to approved research
Programs, and all other miscellaneous project assignments, such as
instrumentation grants, cores of funded projects, a Cancer Information
Service or SEER contract, and the CCSG itself.

For each project provide the direct and total costs (direct and
indirect) for the current year. If an award consists of multiple
projects (e.g., a P01 or SPORE), then list each assignable project with
the name of the PI/name of the project leader as shown in the example
format. P01 and SPORE administrative cores may be assigned to the
non-programmatically aligned (ZY) category. See the example format for
P01s.

Using the same procedure as above, list all training awards and research
career development awards at the end of Summary 2A in a separate
section, following a subtotal of the research grants. Identify all
training grants with the program code "**T**," regardless of the source
or type, including the F, K and T series NIH grants. Provide a subtotal
of the training grants (if any) and a grand total of all grants.

> Summary 2A - Example Format 2P30CA654321-50
>
> Outstanding University Cancer Center
>
> Active Funded Projects as of mm/dd/yyyy

<table>
<colgroup>
<col style="width: 11%" />
<col style="width: 8%" />
<col style="width: 11%" />
<col style="width: 6%" />
<col style="width: 6%" />
<col style="width: 18%" />
<col style="width: 7%" />
<col style="width: 7%" />
<col style="width: 4%" />
<col style="width: 4%" />
<col style="width: 6%" />
<col style="width: 6%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="3"><strong>RESEARCH PROJECTS</strong></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td><strong>PI</strong></td>
<td><strong>Funding<br />
Agency</strong></td>
<td><strong>Grant #</strong></td>
<td><strong>Start Date</strong></td>
<td><strong>End Date</strong></td>
<td><strong>Proj Title</strong></td>
<td><strong>Dir Cost</strong></td>
<td><strong>Tot Cost</strong></td>
<td><strong>Prog<br />
Code</strong></td>
<td><strong>%</strong></td>
<td><strong>Prog Dir</strong></td>
<td><strong>Prog Tot</strong></td>
</tr>
<tr class="odd">
<td>Alfred, L.</td>
<td>NIH</td>
<td>5R01DK059736-04</td>
<td>06/05/95</td>
<td>04/30/05</td>
<td>Regulation of mitochondrial inheritance in yeast</td>
<td>197713</td>
<td>342043</td>
<td>4</td>
<td>100</td>
<td>197713</td>
<td>342043</td>
</tr>
<tr class="even">
<td>Blake, J.</td>
<td>NCI</td>
<td>5P01CA074846-07</td>
<td>07/23/01</td>
<td>04/30/06</td>
<td>Cancer Chemotherapy Program Project (Program Director)</td>
<td>1116373</td>
<td>1931325</td>
<td> </td>
<td> </td>
<td> </td>
<td> </td>
</tr>
<tr class="odd">
<td>Blake/Maleck</td>
<td>NCI</td>
<td>5P01CA074846-07</td>
<td>07/23/01</td>
<td>04/30/06</td>
<td>Cancer Chemotherapy Program Project (Admin Core A)</td>
<td> </td>
<td> </td>
<td>ZY</td>
<td>100</td>
<td>235034</td>
<td>381460</td>
</tr>
<tr class="even">
<td>Blake/Tillis</td>
<td>NCI</td>
<td>5P01CA074846-07</td>
<td>07/23/01</td>
<td>04/30/06</td>
<td>Cancer Chemotherapy Program Project (Pharm Core C)</td>
<td> </td>
<td> </td>
<td>ZY</td>
<td>100</td>
<td>89579</td>
<td>146506</td>
</tr>
<tr class="odd">
<td>Blake/Guzic</td>
<td>NCI</td>
<td>5P01CA074846-07</td>
<td>07/23/01</td>
<td>04/30/06</td>
<td>Cancer Chemotherapy Program Project (Hem Onc Proj. 1)</td>
<td> </td>
<td> </td>
<td>2</td>
<td>100</td>
<td>280531</td>
<td>485088</td>
</tr>
<tr class="even">
<td>Christy, W.</td>
<td>ACS</td>
<td>RPG-96-045-04-1</td>
<td>01/01/98</td>
<td>06/30/04</td>
<td>The role of an HNF-3 protein in c elegan foregut development</td>
<td>103537</td>
<td>128921</td>
<td>2</td>
<td>100</td>
<td>103537</td>
<td>128921</td>
</tr>
<tr class="odd">
<td>Dubois, Y.</td>
<td>NCI</td>
<td>5R01CA067893-02</td>
<td>09/08/97</td>
<td>06/30/03</td>
<td>Star trial (Tamoxifen vs. Raloxifene)</td>
<td>97784</td>
<td>165288</td>
<td>1</td>
<td>50</td>
<td>48892</td>
<td>82644</td>
</tr>
<tr class="even">
<td>Dubois, Y.</td>
<td>NCI</td>
<td>5R01CA067893-02</td>
<td>09/08/97</td>
<td>06/30/03</td>
<td>Star trial (Tamoxifen vs. Raloxifene)</td>
<td> </td>
<td> </td>
<td>5</td>
<td>50</td>
<td>48892</td>
<td>82644</td>
</tr>
<tr class="odd">
<td>Gehr, A.</td>
<td>NCI</td>
<td>5N02C654321-09</td>
<td>04/01/01</td>
<td>05/31/06</td>
<td>Cancer Information Service</td>
<td>1421931</td>
<td>1766530</td>
<td>ZY</td>
<td> </td>
<td> </td>
<td> </td>
</tr>
<tr class="even">
<td>Eutto, M.</td>
<td>NCI</td>
<td>5R01CA083747-03</td>
<td>12/27/02</td>
<td>11/30/03</td>
<td>Genetic epidemiology of breast cancer--BRCA1 and BRCA2</td>
<td>146128</td>
<td>252801</td>
<td>6</td>
<td>100</td>
<td>146128</td>
<td>252801</td>
</tr>
<tr class="odd">
<td>Royce, R.</td>
<td>NIH /Subcon-tract Univ.</td>
<td>5R01HL086850-04</td>
<td>08/01/02</td>
<td>06/30/04</td>
<td>Calpain and p120 catenin regulation of cadherin function</td>
<td>33333</td>
<td>55333</td>
<td>3</td>
<td>100</td>
<td>33333</td>
<td>53333</td>
</tr>
<tr class="even">
<td>Sutton, B.</td>
<td>NCI</td>
<td>5P30CA011189-11</td>
<td>12/01/02</td>
<td>11/30/03</td>
<td>Core Grant</td>
<td>3439815</td>
<td>3760687</td>
<td>ZY</td>
<td> </td>
<td> </td>
<td> </td>
</tr>
<tr class="odd">
<td></td>
<td></td>
<td></td>
<td colspan="2"><strong>Research Subtotals:</strong></td>
<td></td>
<td>6,556,614</td>
<td>8,402,928</td>
<td></td>
<td> </td>
<td>1,183,639</td>
<td>1,955,440</td>
</tr>
<tr class="even">
<td colspan="2"><h6 id="training-projects">TRAINING PROJECTS</h6></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td><strong>PI</strong></td>
<td><strong>Funding<br />
Agency</strong></td>
<td><strong>Grant #</strong></td>
<td><strong>Start Date</strong></td>
<td><strong>End Date</strong></td>
<td><strong>Proj Title</strong></td>
<td><strong>Dir Cost</strong></td>
<td><strong>Tot Cost</strong></td>
<td><strong>ProgCode</strong></td>
<td><strong>%</strong></td>
<td><strong>Prog Dir</strong></td>
<td><strong>Prog Tot</strong></td>
</tr>
<tr class="even">
<td>Adams, Q.</td>
<td>Army</td>
<td>DAMD1702-1-11</td>
<td>09/01/02</td>
<td>08/31/04</td>
<td>Molecular study of bag domains: A new motif in prostate cancer</td>
<td>45368</td>
<td>48997</td>
<td>T</td>
<td>100</td>
<td>45368</td>
<td>48997</td>
</tr>
<tr class="odd">
<td>Burns, W.</td>
<td>NCI</td>
<td>5T32CA009579-01</td>
<td>05/01/87</td>
<td>02/28/04</td>
<td>Cell adhesion and effects on cell behavior</td>
<td>23470</td>
<td>25345</td>
<td>T</td>
<td>100</td>
<td>23470</td>
<td>25345</td>
</tr>
<tr class="even">
<td>Carolan, R.</td>
<td>NIH</td>
<td>F32HL069595-02</td>
<td>07/01/01</td>
<td>06/30/05</td>
<td>Differentiation of a stem cell population in vivo</td>
<td>35585</td>
<td>35585</td>
<td>T</td>
<td>100</td>
<td>35585</td>
<td>35585</td>
</tr>
<tr class="odd">
<td>Dicenza, R.</td>
<td>NIH</td>
<td>K08MH001711-02</td>
<td>07/01/99</td>
<td>06/30/04</td>
<td>Serotonergic mechanisms is stress and anxiety</td>
<td>164882</td>
<td>178071</td>
<td>T</td>
<td>100</td>
<td>164882</td>
<td>178071</td>
</tr>
<tr class="even">
<td></td>
<td></td>
<td></td>
<td colspan="2"><strong>Training Subtotals:</strong></td>
<td></td>
<td>269,305</td>
<td>287,998</td>
<td></td>
<td></td>
<td>269,305</td>
<td>287,998</td>
</tr>
<tr class="odd">
<td></td>
<td></td>
<td></td>
<td colspan="2"><strong>Grand Totals:</strong></td>
<td></td>
<td>6,825,919</td>
<td>8,690,926</td>
<td></td>
<td></td>
<td>1,452,944</td>
<td>2,243,438</td>
</tr>
</tbody>
</table>

#### Summary 2B: Active Funded Projects

List the total number of projects, the sum of direct costs and the sum
of total costs (direct plus indirect) for each major funding agency
category as follows: NCI, other NIH, ACS, NSF, other Peer Reviewed (\*as
defined by NCI in Part II, Eligibility Requirements, of the CCSG
guidelines) and Non Peer Reviewed (Industry-sponsored and Other). The
CCSG and training grants may also be included. Provide subtotals and a
grand total where indicated.

> Summary 2B -- Active Funding (Example Format) 2P30CA654321-50
>
> Outstanding University Cancer Center
>
> Reporting Date: mm/dd/yyyy

  ------------------------------- ------------ ------------------ ------------------
  **Funding Agency**              **Total      **Sum of Direct    **Sum of Total
                                  Number of    Costs**            Costs
                                  Projects**                      (Dir+Indir)**

  NCI                             20           5,579,706          9,085,388

  Other NIH                       47           9,446,080          14,851,293

  ACS                             2            80,000             80,000

  NSF                             5            666,030            1,087,092

  Other Peer Reviewed\*           9            6,420,432          6,967,926

  ***Subtotal of Peer Reviewed*** ***83***     ***22,192,248***   ***32,071,699***

  Industry Non Peer Reviewed      35           3,299,571          3,544,740

  Other Non Peer Reviewed         30           4,013,038          5,472,172

  ***Subtotal of Non Peer         ***65***     ***7,312,609***    ***9,016,912***
  Reviewed***                                                     

  Grand Total (All Projects)      148          29,504,857         41,088,611
  ------------------------------- ------------ ------------------ ------------------

####  

#### Summary 3: Reportable Patients/Participation in Therapeutic Protocols By Anatomic Cancer Site

Summary 3 documents which anatomic cancer sites are being treated at the
cancer center and whether the center is placing these patients onto
therapeutic protocols. Broadly, it summarizes the clinical research
activities of the cancer center. (Note to Reviewers: Accrual data in
Summary 3 and 4 do not correlate exactly and should not be directly
compared.) For clarity and uniformity, use the following definitions:

**Reporting Period:** The 12-month period for which data are being
provided (as defined by the Cancer Center).

**Reportable Cancers:** Malignancies with an International
Classification of Diseases for Oncology -3 (ICD-O-3) behavior code of 2
or 3 should be reported, in accordance with the established requirements
of registry standard setting organizations (see below).

**Reportable Patients:** Reportable patients are those seen face-to-face
and *first registered* at the cancer center, whether as inpatients or
outpatients, *during the reporting period*. All patients registered
should be counted regardless of whether they have a newly diagnosed
cancer or have recurrent disease and were referred to the cancer center
for further evaluation and primary or secondary treatment occurring
after the start date of the reporting period. This category *excludes*
consults (e.g., for service or second opinions), diagnoses at autopsy,
and former patients admitted for rehabilitation purposes or treatment of
some other conditions. It also excludes patient follow up activities
after treatment is completed.

Include data from affiliated institutions if agreements with the
affiliates are sufficiently strong so as to guarantee that all their
cancer patients will be reported to the center's registry. This would
usually be the case, for example, with a children's hospital affiliated
with a general university hospital, but would not apply to "satellite"
institutions that submitted only a portion of their cancer patient
population, or to patients whose only contact with the center was by
virtue of being enrolled on protocol studies organized among com­munity
practitioners by center staff.

**Therapeutic Trials:** Clinical trials with **therapeutic** intent
using drugs, radiation, surgery, other biological agents, or behavioral
or other interventions.

**Table Format**

**Provide the total number of newly registered reportable patients by
anatomical site of cancer for the selected reporting period**, using the
definitions above. Reflect the number of *patients* coming to the cancer
center, not the numbers of visits. *Do not include any patient more than
once unless they have two malignancies diagnosed in the same year*.
Refer to the example format for Summary 3.

**Provide the total number of inpatients and outpatients by anatomic
site that were *newly placed* on therapeutic research protocols during
the selected reporting period**. Refer to the example format for Summary
3. A patient may appear more than once if he/she is on more than one
therapeutic protocol during the reporting period. *Do not include
patients on non-therapeutic trials.*

Summary 3: Reportable Patients/Participation in Therapeutic Protocols
(Example Format) 2P30CA654321-50

Outstanding University Cancer Center

Reporting Period mm/dd/yyyy -- mm/dd/yyyy

  -------------------------------------- ------------ ---------------------
  *Name of Reporting Source*             Newly        Total patients newly
                                         Registered   enrolled in
                                         Patients     **therapeutic**
                                                      protocols

  **Disease Site**                                    

  Lip, Oral Cavity and Pharynx                        

  Esophagus                                           

  Stomach                                             

  Small Intestine                                     

  Colon                                               

  Rectum                                              

  Anus                                                

  Liver                                               

  Pancreas                                            

  Other Digestive Organ                               

  Larynx                                              

  Lung                                                

  Other Respiratory and Intrathoracic                 
  Organs                                              

  Bones and Joints                                    

  Soft Tissue                                         

  Melanoma, skin                                      

  Kaposi's sarcoma                                    

  Mycosis Fungoides                                   

  Other Skin                                          

  Breast -- Female                                    

  Breast -- Male                                      

  Cervix                                              

  Corpus Uteri                                        

  Ovary                                               

  Other Female Genital                                

  Prostate                                            

  Other Male Genital                                  

  Urinary Bladder                                     

  Kidney                                              

  Other Urinary                                       

  Eye and Orbit                                       

  Brain & Nervous System                              

  Thyroid                                             

  Other Endocrine System                              

  Non-Hodgkin's Lymphoma                              

  Hodgkin's Lymphoma                                  

  Multiple Myeloma                                    

  Lymphoid Leukemia                                   

  Myeloid and Monocytic Leukemia                      

  Leukemia, other                                     

  Leukemia, not otherwise specified                   

  Other Hematopoietic                                 

  Unknown Sites                                       

  Ill-Defined Sites                                   

  **TOTAL:**                                          
  -------------------------------------- ------------ ---------------------

International Classification of Diseases for Oncology

ICD-9-CM Codes and cross references to ICD-O-3 Codes to be used with
Summary 3, Patient Information.

+--------------------+--------------------+---------------------------+
| **PRIMARY DISEASE  | **ICD-9-CM** ^1^   | **ICD-O-3** ^2^           |
| SITE**             |                    |                           |
+--------------------+--------------------+---------------------------+
| Lip, Oral Cavity   | 140.0-140.6,       | C000-C006, C008-C009,     |
| and Pharynx        | 140.8, 140.9       | C019-C024, C028-C029,     |
|                    |                    | C030-C031, C039-C041,     |
|                    | 141.0-141.6,       | C048-C052, C058-C062,     |
|                    | 141.8, 141.9       | C068-C069, C079-C081,     |
|                    |                    | C088-C089, C090-C091,     |
|                    | 142.0-142.2,       | C098-C104, C108-C109,     |
|                    | 142.8, 142.9       | C110-C113, C118-C119,     |
|                    |                    | C129-C132, C139-C139,     |
|                    | 143.0, 143.1,      | C140, C142, C148          |
|                    | 143.8, 143.9       |                           |
|                    |                    |                           |
|                    | 144.0, 144.1,      |                           |
|                    | 144.8, 144.9       |                           |
|                    |                    |                           |
|                    | 145.0-145.6,       |                           |
|                    | 145.8, 145.9       |                           |
|                    |                    |                           |
|                    | 146.0-146.9        |                           |
|                    |                    |                           |
|                    | 147.0-147.3,       |                           |
|                    | 147.8, 147.9       |                           |
|                    |                    |                           |
|                    | 148.0-148.3,       |                           |
|                    | 148.8, 148.9       |                           |
|                    |                    |                           |
|                    | 149.0, 149.1,      |                           |
|                    | 149.8, 149.9       |                           |
+--------------------+--------------------+---------------------------+
| Esophagus          | 150.0-150.5,       | C150-C155, C158-C159      |
|                    | 150.8, 150.9       |                           |
+--------------------+--------------------+---------------------------+
| Stomach            | 151.0-151.6,       | C160-C166, C168-C169      |
|                    | 151.8, 151.9       |                           |
+--------------------+--------------------+---------------------------+
| Small Intestine    | 152.0-152.3,       | C170-C173, C178-C179      |
|                    | 152.8, 152.9       |                           |
+--------------------+--------------------+---------------------------+
| Colon              | 153.0-153.9        | C180, C182-C189, C199     |
+--------------------+--------------------+---------------------------+
| Rectum             | 154.0, 154.1       | C209                      |
+--------------------+--------------------+---------------------------+
| Anus               | 154.2, 154.3,      | C210-C212, C218           |
|                    | 154.8              |                           |
+--------------------+--------------------+---------------------------+
| Liver              | 155.0, 155.1       | C220                      |
+--------------------+--------------------+---------------------------+
| Pancreas           | 157.0-157.4,       | C250-C254, C257-C259      |
|                    | 157.8, 157.9       |                           |
+--------------------+--------------------+---------------------------+
| Other Digestive    | 156.0-156.2        | C221, C239-C241,          |
| Organ              |                    | C248-C249                 |
|                    | 159.0, 159.1,      |                           |
|                    | 159.8, 159.9       |                           |
+--------------------+--------------------+---------------------------+
| Larynx             | 161.0-161.3,       | C320-C323, C328-C329      |
|                    | 161.8, 161.9       |                           |
+--------------------+--------------------+---------------------------+
| Lung               | 162.0,             | C340-C343, C348-C349      |
|                    | 162.2-162.5,       |                           |
|                    | 162.8, 162.9       |                           |
+--------------------+--------------------+---------------------------+
| Other Respiratory  | 160.0-160.5,       | C300, C301, C310-C313,    |
| and Intrathoracic  | 160.8, 160.9       | C318-C319, C339, C379,    |
| Organs             |                    | C380, C381-C383, C384,    |
|                    | 163.0, 163.1,      | C388, C390, C398-C399     |
|                    | 163.8, 163.9       |                           |
|                    |                    |                           |
|                    | 164.0-164.3,       |                           |
|                    | 164.8, 164.9       |                           |
|                    |                    |                           |
|                    | 165.0, 165.8,      |                           |
|                    | 165.9              |                           |
+--------------------+--------------------+---------------------------+
| Bones and Joints   | 170.0-170.9        | C400-C403, C408-C414,     |
|                    |                    | C418-C419                 |
+--------------------+--------------------+---------------------------+
| Soft Tissue        | 158.0, 158.8,      | C470-C476, C478-C479,     |
|                    | 158.9              | C480-C482, C488,          |
|                    |                    | C490-C496, C498-C499      |
|                    | 171.0, 171.2-171.9 |                           |
+--------------------+--------------------+---------------------------+
| Melanoma, skin     | 172.0-172.9        | C440-C449                 |
+--------------------+--------------------+---------------------------+
| Kaposi's sarcoma   | 176.0-176.5,       | 9140                      |
|                    | 176.8, 176.9       |                           |
+--------------------+--------------------+---------------------------+
| Mycosis Fungoides  | 202.1              | 9700                      |
+--------------------+--------------------+---------------------------+
| Other Skin         | 173.0-173.9        | 8720-8790                 |
+--------------------+--------------------+---------------------------+
| Breast - Female    | 174.0-174.6,       | C500-C506, C508-C509      |
|                    | 174.8, 174.9       |                           |
+--------------------+--------------------+---------------------------+
| Breast -- Male     | 175.0, 175.9       | C500-C506, C508-C509      |
+--------------------+--------------------+---------------------------+
| Cervix Uteri       | 180.0, 180.1,      | C530-C531, C538-C539      |
|                    | 180.8, 180.9       |                           |
+--------------------+--------------------+---------------------------+
| Corpus Uteri       | 182.0, 182.1,      | C519, C540-C543,          |
|                    | 182.8              | C548-C549, C559           |
|                    |                    |                           |
|                    | 179                |                           |
+--------------------+--------------------+---------------------------+
| Ovary              | 183.0              | C569                      |
+--------------------+--------------------+---------------------------+
| Other Female       | 181                | C510-C512, C518-C519,     |
| Genital            |                    | C570-C574, C577-C579      |
|                    | 183.2-183.5,       |                           |
|                    | 183.8, 183.9       |                           |
|                    |                    |                           |
|                    | 184.0-184.4,       |                           |
|                    | 184.8, 184.9       |                           |
+--------------------+--------------------+---------------------------+
| Prostate           | 185                | C619                      |
+--------------------+--------------------+---------------------------+
| Other Male Genital | 186.0, 186.9       | C600-C602, C608-C609,     |
|                    |                    | C620-C621, C629, C630,    |
|                    | 187.1-187.9        | C631, C632, C637-C639     |
+--------------------+--------------------+---------------------------+
| Bladder            | 188.0-188.9        | C670-C679                 |
+--------------------+--------------------+---------------------------+
| Kidney             | 189.0, 189.1       | C649                      |
+--------------------+--------------------+---------------------------+
| Other Urinary      | 189.2-189.4,       | C659, C669, C680-C681,    |
|                    | 189.8, 189.9       | C688-C689                 |
+--------------------+--------------------+---------------------------+
| Eye and Orbit      | 190.0-190.9        | C690-C691, C692, C693,    |
|                    |                    | C694, C695-C698, C699     |
+--------------------+--------------------+---------------------------+
| Brain and Nervous  | 191.0-191.9        | C700-C701, C709,          |
| System             |                    | C710-C714, C715, C716,    |
|                    | 192.0-192.3,       | C717-C719, C720-C725,     |
|                    | 192.8, 192.9       | C728-C729                 |
+--------------------+--------------------+---------------------------+
| Thyroid            | 193                | C739                      |
+--------------------+--------------------+---------------------------+
| Other Endocrine    | 194.0, 194.1,      | C740-C741, C749, C750,    |
| System             | 194.3-194.6,       | C751-C752, C753,          |
|                    | 194.8, 194.9       | C754-C755, C758-C759      |
+--------------------+--------------------+---------------------------+
| Non-Hodgkin's      | 200.0-200.2, 200.8 | 9590-9591, 9596,          |
| Lymphoma           |                    | 9670-9671, 9673, 9675,    |
|                    | 202.0, 202.8       | 9678-9680, 9684, 9687,    |
|                    |                    | 9689-9691, 9695,          |
|                    |                    | 9698-9699                 |
+--------------------+--------------------+---------------------------+
| Hodgkin's Lymphoma | 201.0-201.2,       | 9650-9655, 9659,          |
|                    | 201.4-201.7, 201.9 | 9661-9665, 9667           |
+--------------------+--------------------+---------------------------+
| Multiple Myeloma   | 203.0, 203.1       | 9732-9733                 |
+--------------------+--------------------+---------------------------+
| Lymphoid Leukemia  | 204.0-204.2,       | 9820, 9823, 9826-9828,    |
|                    | 204.8, 204.9       | 9832-9837                 |
+--------------------+--------------------+---------------------------+
| Myeloid and        | 205.0-205.3,       | 9860-9861, 9863,          |
| Monocytic Leukemia | 205.8, 205.9       | 9866-9867, 9870-9876, and |
|                    |                    | 9891, 9895-9897, 9910,    |
|                    | 206.0-206.2,       | 9920, 9930-9931           |
|                    | 206.8, 206.9       |                           |
+--------------------+--------------------+---------------------------+
| Leukemia, other    | 202.4              | 9940, 9945-9946, 9948     |
|                    |                    |                           |
|                    | 207.0-207.2, 207.8 |                           |
+--------------------+--------------------+---------------------------+
| Leukemia, not      | 208.0-208.2,       | 9800-9801, 9805           |
| otherwise          | 208.8, 208.9       |                           |
| specified          |                    |                           |
+--------------------+--------------------+---------------------------+
| Other              | 202.3, 202.5,      | 9731, 9760-9762,          |
| Hematopoietic      | 202.6, 202.9       | 9740-9741, 9750,          |
|                    |                    | 9754-9758, 9950,          |
|                    | 203.8              | 9960-9964, 9980,          |
|                    |                    | 9982-9987,9989            |
|                    | 238.6, 238.7       |                           |
+--------------------+--------------------+---------------------------+
| Unknown Sites      | 199.0, 199.1       | C809                      |
+--------------------+--------------------+---------------------------+
| Ill-Defined Sites  | 195.0-195.5, 195.8 | C760-C768                 |
+--------------------+--------------------+---------------------------+

^1^ The International Classification of Diseases, Ninth Revision,
Clinical Modification (ICD-9-CM) is based on the World Health
Organization\'s Ninth Revision, International Classification of Diseases
(ICD-9).

^2^ International Classification of Diseases for Oncology, 3rd Edition
(ICD-O-3). Used principally in tumor or cancer registries for coding the
site (topography) and the histology (morphology) of neoplasms, usually
obtained from a pathology report.

**Summary 4: Information on Clinical Research Studies**

> Using the example format for Summary 4, produce a report of the
> clinical research studies open at any time at your cancer center
> during the defined reporting period.

**[Name of Institution]{.underline}:** Insert the name of the cancer
center at the top of each page.

**[Reporting period]{.underline}**: Insert the 12-month period for which
data are being provided (as defined by the cancer center).

***Sort the report in the following order according to the instructions
below (also see sample format):***

**[1. Clinical Research Category]{.underline}**:

-   clinical trials involving *an agent or device*;

-   clinical trials involving *other types of intervention*s (i.e.
    behavioral modification, nutritional protocols, etc.);

-   epidemiologic, outcome, or other observational studies;

-   ancillary or correlative studies associated with a clinical trial
    and other biological studies using clinical specimens *that can be
    linked to individual patient or participant data***.**

**2. [Trial Sponsor (For clinical trials involving an agent or device or
other intervention *only):*]{.underline}**

-   **National Cooperative Group Trials:** Place an asterisk \[\*\] next
    to any trials authored by an investigator at your institution.

-   **Other Externally Peer-Reviewed Trials:** R01s and P01s or other
    trial mechanisms funded by NIH or supported by other peer-reviewed
    funding organizations, such as the ACS, the Komen Foundation, etc.
    Place two asterisks \[\*\*\] next to any multi-site trials authored
    by an investigator at your institution.

-   **Institutional Trials:** In-house, internally reviewed trials,
    *including those collaborative studies conducted with industry
    sponsorship in which the center is a primary contributor to the
    design,* *implementation, and monitoring of the trial, or
    participation in a multi-site trial initiated by an investigator at
    another center.* Place two asterisks \[\*\*\] next to any multi-site
    trials authored by an investigator at your institution.

-   **Industrial** **Trials:** Design and implementation of the study is
    controlled by the pharmaceutical company.

**3. [Last name of the principal investigator, in alphabetic
order]{.underline}**

######### **[Table Format]{.underline}**

**Provide a column in the report, in the order provided, for each of the
data items listed below:**

**Group/Sponsor/Funding Source:** Provide the name of the external
sponsor or funding source. For national group trials, use CALGB, CCG,
ECOG, GOG, NSABP, POG, RTOG, and SWOG. For externally peer-reviewed
trials or other clinical research studies, list the funding agency. For
industrially sponsored research, **list the name of the pharmaceutical
sponsor.** For institutionally sponsored trials or studies, list the
names of the applicable funding agencies, including the parent
institution, pharmaceutical company, or in the case of a multi-site
study, the name of the other sponsoring cancer center.

**Anatomic Site (Site):** Identify the anatomic cancer site(s) (i.e.
breast, ovary) on which the trial or study is focused. If a feasibility
or early phase trial or other clinical study is broadly applicable to a
number of potential anatomic sites, enter the term "multiple" in this
column.

**Protocol ID/IRB Number:** Provide the unique identifier for this
study. For both national and externally reviewed trials, list the common
protocol number that the trial is known under nationally (if one
exists), followed by the internal institutional number. For both
institutional and industrial trials and other types of studies, use an
internal protocol identification number or IRB number.

**Principal Investigator (PI):** Provide the **last name and first
initial** of the Principal Investigator from your center who is
responsible for this study.

**Program (Prog):** Provide the program code at your center that
includes this protocol or study. **Use the codes defined in Summary
1B.**

**Date Opened:** Provide the date that this protocol or study was opened
to accrual at your center.

**Date Closed:** If the protocol or clinical research study was closed
to accrual at your center during the 12-month reporting period, provide
the date it was closed.

**Phase:** For clinical trials, p**r**ovide the study phase.
**Acceptable phases are pilot, feasibility, I, II, III, IV, or
combinations such as I/II.** For epidemiologic, cancer
control/behavioral, observational, ancillary, correlative or other
biological studies, indicate "N/A."

**Trial/Study Type (Type):** Identify the type of trial or clinical
research study, as follows:

-   **Therapeutic (The) Trial:** Clinical trials with **therapeutic**
    intent using drugs, radiation, surgery, other biological agents, or
    behavioral or other interventions.

-   **Prevention (Pre) Trial:** Clinical trials for the modulation of
    cancer risk and inhibition of cancer progression using
    chemoprevention drugs, nutritional, dietary, behavioral, or other
    interventions.

-   **Supportive Care (Sup) Trial:** Clinical trials intended to improve
    the comfort and quality of life for the patient using drugs,
    nutritional, dietary, behavioral or other interventions.

-   **Screening (Scr), Early Detection (Det), or Diagnostic (Dia)
    Trials:** Clinical trials directly testing the efficacy of devices,
    techniques, procedures; or tests for earlier or more accurate
    detection or diagnosis of disease.

-   **Epidemiologic (Epi), Observational (Obs), or Outcome (Out)
    Trials:** Studies among cancer patients and healthy populations that
    involve no intervention or alteration in the status of the
    participants, e.g., surveillance, risk assessment, outcome,
    environmental, and behavioral studies.

-   **Ancillary (Anc) Trial:** Auxiliary studies that are stimulated by,
    but are not a required part of, a main clinical trial/study, and
    that utilize patient or other resources of the main trial/study to
    generate information relevant to it. Ancillary studies included must
    be linked to an active trial or epidemiologic or other study and
    should include only patients accrued to that trial or study. Only
    studies that can be linked to individual patient or participant data
    should be reported.

-   **Correlative (Cor) Trial:** Laboratory based studies using
    specimens to assess cancer risk, clinical outcomes, response to
    therapies, etc. Only studies that can be linked to individual
    patient or participant data should be reported.

**Title:** Provide a concise title for this trial or study (limited to
100 characters or fewer).

**Target:** Indicate the total number of patients or participants needed
for the entire study (i.e. the targeted accrual) as stated in the
protocol or study. Do **not** submit a targeted range, such as "10 --
100." If this is a multi-institutional or national trial authored by an
investigator at another institution, cite only the number of patients or
participants the cancer center expects to accrue over the next 12 months
of the reporting period. If the center **initiated** the multi-site
trial/study, enter both the number of patients or participants needed
for the entire study across all participating sites (in parentheses),
and the number of patients or participants to be accrued by the center
during the next 12 months of the reporting period.

**Accrual Site:**

-   **Cancer Center (Primary):** Create an accrual reporting column for
    patients involved in clinical trials at the primary hospital or
    treatment facility of the cancer center and healthy subjects
    involved in other clinical research at the cancer center.

-   **Other (optional):** Create a separate patient/healthy subject
    accrual reporting column for all additional hospital or treatment
    facilities or research facilities closely associated with the cancer
    center (e.g., VA, Children's Hospital, other teaching hospital or
    research facility).

**Accrual Timeframes:**

-   **12 Mos:** For each **applicable** accrual site reporting column,
    provide a count of the number of patients that were accrued to this
    trial or study during the identified 12-month reporting period.

-   **To Date:** For each **applicable** accrual site reporting column,
    provide a count of the number of patients accrued to this trial to
    date. This is a cumulative figure, not an annual total.

Summary 4 - Clinical Research Protocols (Example Format) (Center with
Affiliates) 2P30CA654321-50

Outstanding University Cancer Center

Reporting Period: mm/dd/yyyy -- mm/dd/yyyy

Report Prepared: mm/dd/yyyy

SECTION 1 (Agent or Device)

<table style="width:100%;">
<colgroup>
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 7%" />
<col style="width: 3%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 4%" />
<col style="width: 4%" />
<col style="width: 25%" />
<col style="width: 5%" />
<col style="width: 6%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="11"><strong>NATIONAL</strong></td>
<td colspan="4"><strong>ACCRUAL</strong></td>
</tr>
<tr class="even">
<td><strong>Sponsor</strong></td>
<td><strong>Site</strong></td>
<td><strong>Proto ID</strong></td>
<td><strong>PI</strong></td>
<td><strong>Prog</strong></td>
<td><strong>Date<br />
Opened</strong></td>
<td><strong>Date<br />
Closed</strong></td>
<td><strong>Phase</strong></td>
<td><strong>Type</strong></td>
<td><strong>Title</strong></td>
<td><strong>Target</strong></td>
<td><p><strong>Center</strong></p>
<p><strong>12 mos</strong></p></td>
<td><p><strong>Center</strong></p>
<p><strong>To Date</strong></p></td>
<td><p><strong>Other</strong></p>
<p><strong>12 mos</strong></p></td>
<td><p><strong>Other</strong></p>
<p><strong>To Date</strong></p></td>
</tr>
<tr class="odd">
<td>GOG</td>
<td>Cervix</td>
<td>106</td>
<td>Smith, J</td>
<td>5</td>
<td>1/25/00</td>
<td></td>
<td>II</td>
<td>The</td>
<td>Evaluation of Gemcitabine in Persistent or Recurrent Non-Squamous
Cell Carcinoma of the Cervix</td>
<td>2</td>
<td>0</td>
<td>1</td>
<td>0</td>
<td>1</td>
</tr>
<tr class="even">
<td>ECOG</td>
<td>Bladder</td>
<td>9638</td>
<td>*Saperstein, R</td>
<td>4</td>
<td>1/17/99</td>
<td></td>
<td>II</td>
<td>The</td>
<td>Study of Paclitaxel plus Carboplatin in patients with advanced
carcinoma of the bladder</td>
<td>4</td>
<td>0</td>
<td>4</td>
<td>0</td>
<td>0</td>
</tr>
</tbody>
</table>

<table>
<colgroup>
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 7%" />
<col style="width: 3%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 4%" />
<col style="width: 4%" />
<col style="width: 25%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="11"><strong>EXTERNALLY PEER-REVIEWED</strong></td>
<td colspan="4"><strong>ACCRUAL</strong></td>
</tr>
<tr class="even">
<td><strong>Sponsor</strong></td>
<td><strong>Site</strong></td>
<td><strong>Proto ID</strong></td>
<td><strong>PI</strong></td>
<td><strong>Prog</strong></td>
<td><strong>Date<br />
Opened</strong></td>
<td><strong>Date<br />
Closed</strong></td>
<td><strong>Phase</strong></td>
<td><strong>Type</strong></td>
<td><strong>Title</strong></td>
<td><strong>Target</strong></td>
<td><p><strong>Center</strong></p>
<p><strong>12 mos</strong></p></td>
<td><p><strong>Center</strong></p>
<p><strong>To Date</strong></p></td>
<td><p><strong>Other</strong></p>
<p><strong>12 mos</strong></p></td>
<td><p><strong>Other</strong></p>
<p><strong>To Date</strong></p></td>
</tr>
<tr class="odd">
<td>NCI</td>
<td>Ovarian</td>
<td>9971</td>
<td>Ryabinsky, D</td>
<td>5</td>
<td>9/24/02</td>
<td></td>
<td>N/A</td>
<td>Dia</td>
<td>Detection of Ovarian specific markers in the peripheral blood in
high risk women</td>
<td>50</td>
<td>2</td>
<td>8</td>
<td>10</td>
<td>10</td>
</tr>
</tbody>
</table>

<table>
<colgroup>
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 7%" />
<col style="width: 3%" />
<col style="width: 5%" />
<col style="width: 4%" />
<col style="width: 4%" />
<col style="width: 4%" />
<col style="width: 25%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="11"><strong>INSTITUTIONAL</strong></td>
<td colspan="4"><strong>ACCRUAL</strong></td>
</tr>
<tr class="even">
<td><strong>Sponsor</strong></td>
<td><strong>Site</strong></td>
<td><strong>Proto ID</strong></td>
<td><strong>PI</strong></td>
<td><strong>Prog</strong></td>
<td><strong>Date<br />
Opened</strong></td>
<td><strong>Date<br />
Closed</strong></td>
<td><strong>Phase</strong></td>
<td><strong>Type</strong></td>
<td><strong>Title</strong></td>
<td><strong>Target</strong></td>
<td><p><strong>Center</strong></p>
<p><strong>12 mos</strong></p></td>
<td><p><strong>Center</strong></p>
<p><strong>To Date</strong></p></td>
<td><p><strong>Other</strong></p>
<p><strong>12 mos</strong></p></td>
<td><p><strong>Other</strong></p>
<p><strong>To Date</strong></p></td>
</tr>
<tr class="odd">
<td>OUCC</td>
<td>Multiple</td>
<td>02-010</td>
<td>Booker, M</td>
<td>4</td>
<td>6/9/01</td>
<td></td>
<td>I</td>
<td>The</td>
<td>Ph 1 trial of subcutaneous and/or oral calciriol [(1,25-COH)2D3] and
Carboplatin in advanced solid tumors</td>
<td>100</td>
<td>16</td>
<td>51</td>
<td>5</td>
<td>12</td>
</tr>
</tbody>
</table>

<table>
<colgroup>
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 7%" />
<col style="width: 3%" />
<col style="width: 5%" />
<col style="width: 4%" />
<col style="width: 4%" />
<col style="width: 4%" />
<col style="width: 25%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="11"><strong>INDUSTRIAL</strong></td>
<td colspan="4"><strong>ACCRUAL</strong></td>
</tr>
<tr class="even">
<td><strong>Sponsor</strong></td>
<td><strong>Site</strong></td>
<td><strong>Proto ID</strong></td>
<td><strong>PI</strong></td>
<td><strong>Prog</strong></td>
<td><strong>Date<br />
Opened</strong></td>
<td><strong>Date<br />
Closed</strong></td>
<td><strong>Phase</strong></td>
<td><strong>Type</strong></td>
<td><strong>Title</strong></td>
<td><strong>Target</strong></td>
<td><p><strong>Center</strong></p>
<p><strong>12 mos</strong></p></td>
<td><p><strong>Center</strong></p>
<p><strong>To Date</strong></p></td>
<td><p><strong>Other</strong></p>
<p><strong>12 mos</strong></p></td>
<td><p><strong>Other</strong></p>
<p><strong>To Date</strong></p></td>
</tr>
<tr class="odd">
<td>Superph</td>
<td>Leukemia</td>
<td>SP-990</td>
<td>Gonzalez, R</td>
<td>4</td>
<td>7/3/01</td>
<td></td>
<td>II</td>
<td>The</td>
<td>Genasense (Bcl-2 Antisense) combined with Mylotarg (gemtuzumab
ozogamicin) in elderly patients with relapsed acute myeloid
leukemia</td>
<td>5</td>
<td>0</td>
<td>1</td>
<td>1</td>
<td>1</td>
</tr>
</tbody>
</table>

SECTION 2 (Trials Involving other Interventions)

<table>
<colgroup>
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 7%" />
<col style="width: 3%" />
<col style="width: 5%" />
<col style="width: 4%" />
<col style="width: 4%" />
<col style="width: 4%" />
<col style="width: 25%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="11"><strong>NATIONAL</strong></td>
<td colspan="4"><strong>ACCRUAL</strong></td>
</tr>
<tr class="even">
<td><strong>Sponsor</strong></td>
<td><strong>Site</strong></td>
<td><strong>Proto ID</strong></td>
<td><strong>PI</strong></td>
<td><strong>Prog</strong></td>
<td><strong>Date<br />
Opened</strong></td>
<td><strong>Date<br />
Closed</strong></td>
<td><strong>Phase</strong></td>
<td><strong>Type</strong></td>
<td><strong>Title</strong></td>
<td><strong>Target</strong></td>
<td><p><strong>Center</strong></p>
<p><strong>12 mos</strong></p></td>
<td><p><strong>Center</strong></p>
<p><strong>To Date</strong></p></td>
<td><p><strong>Other</strong></p>
<p><strong>12 mos</strong></p></td>
<td><p><strong>Other</strong></p>
<p><strong>To Date</strong></p></td>
</tr>
<tr class="odd">
<td>ECOG</td>
<td>Prostate</td>
<td>CRJ-51</td>
<td>Harshman, A</td>
<td>4</td>
<td>1/7/95</td>
<td></td>
<td>Pilot</td>
<td>Sup</td>
<td>Randomized trial to study whether an outpatient educational and
behavioral skills training program will improve pain control in patients
who have metastatic or recurrent prostate cancer</td>
<td>225</td>
<td>15</td>
<td>191</td>
<td>19</td>
<td>19</td>
</tr>
</tbody>
</table>

<table>
<colgroup>
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 7%" />
<col style="width: 3%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 4%" />
<col style="width: 4%" />
<col style="width: 25%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="11"><strong>EXTERNALLY PEER-REVIEWED</strong></td>
<td colspan="4"><strong>ACCRUAL</strong></td>
</tr>
<tr class="even">
<td><strong>Sponsor</strong></td>
<td><strong>Site</strong></td>
<td><strong>Proto ID</strong></td>
<td><strong>PI</strong></td>
<td><strong>Prog</strong></td>
<td><strong>Date<br />
Opened</strong></td>
<td><strong>Date<br />
Closed</strong></td>
<td><strong>Phase</strong></td>
<td><strong>Type</strong></td>
<td><strong>Title</strong></td>
<td><strong>Target</strong></td>
<td><p><strong>Center</strong></p>
<p><strong>12 mos</strong></p></td>
<td><p><strong>Center</strong></p>
<p><strong>To Date</strong></p></td>
<td><p><strong>Other</strong></p>
<p><strong>12 mos</strong></p></td>
<td><p><strong>Other</strong></p>
<p><strong>To Date</strong></p></td>
</tr>
<tr class="odd">
<td>NCI</td>
<td>Multi</td>
<td>93-55</td>
<td>Prince, A</td>
<td>2</td>
<td>3/5/02</td>
<td></td>
<td>N/A</td>
<td>Pre</td>
<td>Teen smoking prevention and cessation via CD ROM program</td>
<td>500</td>
<td>46</td>
<td>210</td>
<td>0</td>
<td>0</td>
</tr>
</tbody>
</table>

<table>
<colgroup>
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 7%" />
<col style="width: 3%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 4%" />
<col style="width: 4%" />
<col style="width: 25%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="11"><strong>INSTITUTIONAL</strong></td>
<td colspan="4"><strong>ACCRUAL</strong></td>
</tr>
<tr class="even">
<td><strong>Sponsor</strong></td>
<td><strong>Site</strong></td>
<td><strong>Proto ID</strong></td>
<td><strong>PI</strong></td>
<td><strong>Prog</strong></td>
<td><strong>Date<br />
Opened</strong></td>
<td><strong>Date<br />
Closed</strong></td>
<td><strong>Phase</strong></td>
<td><strong>Type</strong></td>
<td><strong>Title</strong></td>
<td><strong>Target</strong></td>
<td><p><strong>Center</strong></p>
<p><strong>12 mos</strong></p></td>
<td><p><strong>Center</strong></p>
<p><strong>To Date</strong></p></td>
<td><p><strong>Other</strong></p>
<p><strong>12 mos</strong></p></td>
<td><p><strong>Other</strong></p>
<p><strong>To Date</strong></p></td>
</tr>
<tr class="odd">
<td>OUCC</td>
<td>Lip, Oral Cavity</td>
<td>3929</td>
<td>Collyer, E</td>
<td>2</td>
<td>9/7/00</td>
<td></td>
<td>N/A</td>
<td>The</td>
<td>Biobehavioral interventions for oral pain</td>
<td>70</td>
<td>13</td>
<td>13</td>
<td>6</td>
<td>23</td>
</tr>
</tbody>
</table>

**SECTION 3 (Epidemiologic or other Observational Studies**)

<table style="width:100%;">
<colgroup>
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 6%" />
<col style="width: 3%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 4%" />
<col style="width: 4%" />
<col style="width: 25%" />
<col style="width: 5%" />
<col style="width: 6%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
</colgroup>
<tbody>
<tr class="odd">
<td><strong>Sponsor</strong></td>
<td><strong>Site</strong></td>
<td><strong>Proto ID</strong></td>
<td><strong>PI</strong></td>
<td><strong>Prog</strong></td>
<td><strong>Date<br />
Opened</strong></td>
<td><strong>Date<br />
Closed</strong></td>
<td><strong>Phase</strong></td>
<td><strong>Type</strong></td>
<td><strong>Title</strong></td>
<td><strong>Target</strong></td>
<td><p><strong>Center</strong></p>
<p><strong>12 mos</strong></p></td>
<td><p><strong>Center</strong></p>
<p><strong>To Date</strong></p></td>
<td><p><strong>Other</strong></p>
<p><strong>12 mos</strong></p></td>
<td><p><strong>Other</strong></p>
<p><strong>To Date</strong></p></td>
</tr>
<tr class="even">
<td>NCI</td>
<td>Ovarian</td>
<td>3315</td>
<td>Lemon, J</td>
<td>3</td>
<td>6/1/00</td>
<td></td>
<td>N/A</td>
<td>Epi</td>
<td>Exogenous hormone use and risk of ovarian cancer</td>
<td>55</td>
<td>12</td>
<td>49</td>
<td>2</td>
<td>5</td>
</tr>
</tbody>
</table>

**SECTION 4 (Ancillary or Correlative Studies**)

<table style="width:100%;">
<colgroup>
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 6%" />
<col style="width: 3%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 4%" />
<col style="width: 4%" />
<col style="width: 25%" />
<col style="width: 5%" />
<col style="width: 6%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
</colgroup>
<tbody>
<tr class="odd">
<td><strong>Sponsor</strong></td>
<td><strong>Site</strong></td>
<td><strong>Proto ID</strong></td>
<td><strong>PI</strong></td>
<td><strong>Prog</strong></td>
<td><strong>Date<br />
Opened</strong></td>
<td><strong>Date<br />
Closed</strong></td>
<td><strong>Phase</strong></td>
<td><strong>Type</strong></td>
<td><strong>Title</strong></td>
<td><strong>Target</strong></td>
<td><p><strong>Center</strong></p>
<p><strong>12 mos</strong></p></td>
<td><p><strong>Center</strong></p>
<p><strong>To Date</strong></p></td>
<td><p><strong>Other</strong></p>
<p><strong>12 mos</strong></p></td>
<td><p><strong>Other</strong></p>
<p><strong>To Date</strong></p></td>
</tr>
<tr class="even">
<td>GOG</td>
<td>Ovarian</td>
<td>D9902</td>
<td>Schubert, W</td>
<td>3</td>
<td>1/24/01</td>
<td></td>
<td>N/A</td>
<td>Anc</td>
<td>Protocol for collecting and banking ovarian cancer specimens</td>
<td>25</td>
<td>5</td>
<td>10</td>
<td>4</td>
<td>4</td>
</tr>
</tbody>
</table>

#### Summary 5: Comparison of Current and Requested CCSG Budgets

Using the attached format as a guide, provide the current CCSG budget
(middle column), and the requested budget for the first year of the
renewal application (right column) for each major budget category listed
on the left. List the shared resources individually, as shown in the
examples. Subcategorize developmental funds into recruitments, interim
support, pilot projects, and new shared resources, etc. Show a sum of
the total direct costs at the bottom of the chart.

The current budget, including the budget for each category and total
direct costs, should reflect the last full year of the current
competitive segment as submitted in the type 5 application and/or as
detailed in the notice of award for that period, *exclusive of carryover
funds and supplements*[.]{.underline} The direct cost figures should
include any third party indirect costs, since these are charged as
direct costs to the CCSG.

> Summary 5: Summary and Comparison of Current and Requested CCSG
> Budgets (Example Format) 2P30CA654321-50
>
> **Outstanding University Cancer Center**

+------------------------+----------------------+----------------------+
| CCSG Budget Category   | Current Budget       | Requested Budget     |
|                        | (direct costs)**\*** | (direct costs)       |
|                        |                      |                      |
|                        | \[insert date e.g.,  | \[insert date e.g.,  |
|                        | 01/01/0X--           | 01/01/0X --          |
|                        | 12/31/0X\]           | 12/31/0X\]           |
|                        |                      |                      |
|                        | Last full year of    | First full year of   |
|                        | current competitive  | competitive          |
|                        | grant                | application          |
+------------------------+----------------------+----------------------+
| ######                 |                      |                      |
| Professional Personnel |                      |                      |
|                        |                      |                      |
| Senior Leadership      |                      |                      |
|                        |                      |                      |
| Major Program          |                      |                      |
| Directors              |                      |                      |
|                        |                      |                      |
| Staff Investigators    |                      |                      |
|                        |                      |                      |
| Subtotal               |                      |                      |
|                        |                      |                      |
| ###### Administration  |                      |                      |
|                        |                      |                      |
| **Planning &           |                      |                      |
| Evaluation**           |                      |                      |
|                        |                      |                      |
| **Shared Resources and |                      |                      |
| Services**             |                      |                      |
|                        |                      |                      |
| Examples:              |                      |                      |
|                        |                      |                      |
| Animal Facility        |                      |                      |
|                        |                      |                      |
| Flow Cytometry Shared  |                      |                      |
| Resource               |                      |                      |
|                        |                      |                      |
| Electron Microscope    |                      |                      |
| Shared Resource        |                      |                      |
|                        |                      |                      |
| Etc.                   |                      |                      |
|                        |                      |                      |
| Subtotal               |                      |                      |
|                        |                      |                      |
| ###### Protocol Review |                      |                      |
|  and Monitoring System |                      |                      |
|                        |                      |                      |
| **Protocol Specific    |                      |                      |
| Research**             |                      |                      |
|                        |                      |                      |
| **Developmental        |                      |                      |
| funds**                |                      |                      |
+------------------------+----------------------+----------------------+
| **Total Direct Costs** |                      |                      |
+------------------------+----------------------+----------------------+

**\*Exclusive of Carryover Funds and Supplements and inclusive of third
party indirect cost**