# Presentation: 433619

## The Early Detection Research Network

**Pre-submission Meeting**
**November 3****rd****, 2004**

**Jacob Kagan, M.Sc., Ph.D.**
**Cancer Biomarkers Research Group**
**Division of Cancer Prevention**
**National Cancer Institute**

## The NCI Challenge

**“****To eliminate the suffering and death due to cancer by 2015”**
**Andrew C. von Eschenbach, M.D., the NCI Director**

## NCI’s Areas of Strategic Focus

**Strategic Development of Cancer Interventions**** ****(including identification of new targets)**
**Molecular Epidemiology**
**Integrated Cancer Biology**
**Early Detection, Prevention, Prediction**
**Integrated Clinical Trials Systems**
**Other Health Disparities**
**Bioinformatics**
**Re-Engineering the Intramural Program**

**http://www.cancer.gov**

## Early Detection Research Network (EDRN)

**Early Detection Research Network (EDRN)**
- _[http://www.cancer.gov/edrn](http://www.cancer.gov/edrn)_

## Early Detection Research NetworkBackground

-    Proposed By:
-      **Early Detection Implementation Group (Jan.- Aug., 1998)**

-   Approach Supported by:
** ****Colon Cancer Progress Review Group (2001)**
** ****Lung Cancer Progress Review Group (2002)**
** ****Stomach and Esophageal Cancer Progress Review Group (2002)**
** ****Pancreatic Cancer Progress Review Group (2002)**
** ****Kidney and Bladder Cancer Progress Review Group (2002)**
** ****Gynecologic Cancer Progress Review Group (2002)**

## Supporting Laboratories/Centers Across the Country: 32 funded laboratories and centers: approximately 120 participating institutions; approximately 300 investigators 

**Washington (2)**

**California (2)**

**Texas (5)**

**Nebraska (1)**

**Colorado (1)**

**Alabama (1)**

**Florida (1)**

**Georgia (1)**

**N. Carolina (1)**

**Virginia (1)**

**Maryland (7)**

**Pennsylvania (2)**

**Connecticut (1)**

**Massachusetts (2)**

**Illinois (1)**

**Michigan (2)**

**New York (1)**

**Supporting Laboratories/Centers Across the Country:** **32 funded laboratories and centers: approximately 120 participating institutions; approximately 300 investigators **

- Note: Number in parenthesis indicates the number of awardees

- 6b

**Early Detection Research Network**

## Early Detection Research Network (EDRN) 

** **Develop and Test Promising Biomarkers and Technologies
- 	for Early Detection and Risk Assessment
-  Validate Promising Biomarkers for Detection, Early
-     Detection and Prognosis of Cancer
-  Promote Collaboration between Academia
-    and Industry to Accelerate the Development and
-    Application of New Biomarkers
-  Promote Rapid Dissemination of Information on
-     Biomarkers and Validated Biomarkers

**Early Detection Research Network (EDRN)**
**Goals of the Network **

## Early Detection Research  Network

**Biomarkers Development**

**Functional Genomics**
**       ****(Proteomics)**

**Serum Markers**

**Gene specific**
**Mutation**

**Expression Profiles**

**Tissue **
**Markers**

**Tissue Markers**

**Body Fluids Markers**

**Molecular Signatures**

**Cancer Prevention**

**Early Detection Research  Network**

## Early Detection Research Network 

**3 laboratories**
**NIST, UCLA and UAB**

**18 laboratories **

**2 centers**
**FHCRC and JPL**

## EDRN Committees

**Executive Committee**

**Composed of EDRN Chair, Co-Chair, Chairs of EDRN **
**collaborative groups and NCI coordinator**
**Approves collaborative studies, validation studies, **
**associate members, supplements, other funding decisions**
**Meets monthly**

**Steering Committee**

**Composed of all EDRN members and NCI coordinator **
**Scientific management and oversight of Network activities **
**Monitors DMCC activities**
**Meets twice a year**

**Network Consulting Committee**

**Non-EDRN members**
**Advise EDRN to meet its goal**
**Meets every two years**

## Collaboration

**    ****Collaborations**
**	****-  Breast and Gynecologic Cancers**
**	****-  Colon and other Gastrointestinal Cancers**
**	****-  Lung and Upper Aerodigestive Cancers**
**	****-  Prostate and Other Urologic Cancers**
** ****Collaborations are Abound: Several Collaborations  **
**   ****with Clinical Programs/Trial Community in Progress**
**	****-  SPORE and CGN (Ovarian Markers)**
**	****-  CARET (Proteomics)**
**               ****-  PCPT (Prostate) **
**               ****-  Ob/Gyn Oncology Group and International **
**                  ****Gynecologic Cancer Inter-group**

**Collaboration**

## Public Private Partnership

**Centers for Disease Control and Prevention**
**National Institute of Standards and Technology**
**Jet Propulsion Laboratory**
**Food and Drug Administration**
**Pacific Northwest National Laboratories (DOE)**

**Basic **
**Science**

**Bioinformatics/**
**Resources**

**Clinical**

**Industry**

**Academia**

**Government**

**EDRN**

**Public Private Partnership**

**Early Detection Research Network**

## EDRN Informatics

**EDRN Informatics**

## BUILDING INFORMATICS

-    Common Data Elements, Statistical and Computational 	Tools, and other decision support tools
-   EDRN Research Network Exchange “ ERNE” to connect 	sites with biorepositories and other clinical databases 	(Virtual Warehouse)
-   Web-based Portal for sharing data, exchanging data, and    	depositing data on specimens, protocols, IRB, etc.

**BUILDING INFORMATICS**

**EDRN Developed:**

## Common Data Elements

**Provide a common “language” for the specification of data terms and values**
**Critical to ****normalizing**** data capture**
**Critical to ****data sharing**
**Critical to ****search and retrieval**
**EDRN CDE examples include**
**Standards for ****epidemiological ****data sets**
**Standards for ****bio-specimen ****data sets**
**EDRN ****Working Groups**** developing new CDEs**

## EDRN Resource Network Exchange Tool

**UT Health Science Center, San Antonio, TX (CEC)**

**Moffitt Cancer Center, Tampa (BDL)**

**Fred Hutchinson Cancer Research Center, Seattle (DMCC)**

**University of Colorado (BDL)**

**University of Michigan /GLNE (CEC)**

**Creighton University (CEC)**

**Build a national data sharing infrastructure to support **
**collaboration in biomedical research for EDRN**

**As of September 2003**

**University of **
**Pittsburgh (BDL)**

**NYU (CEC)**

**Brigham and women **
**Hospital, (CEC)**
**Boston, MA**

**M. D. Anderson (CEC)**
**Huston, TX**

## Rollout of EDRN Informatics Infrastructure

- Userquery

**EDRN Secure Website**

- QueryClient

- Web server

- search.jsp

- Product Server
- UT, San Antonio

- Product ServerMoffitt

- Product Server
- Creighton Univ

- Product Server
- Univ of Pittsburgh

- Product ServerUniv of Colorado

- Product Server
- GLNE

- EDRN Profile
- Server

- EDRN CDE Mapping Database

- Specimen
- Database

- Specimen
- Database

- Specimen
- Database

- Specimen
- Database

- Specimen
- Database

- Specimen
- Database

- DMCC – Fred Hutchinson Cancer Research Center

**Rollout of EDRN Informatics Infrastructure**

- EDRN Resource Network Exchange

## Biological Marker (Biomarker)  

_**Biological Marker (Biomarker)**_** **** **
**A characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention.**

**Source: Biomarker Definitions Working Group - 1998**

## Phases of Biomarker Development and Validation

**Phases of Biomarker Development and Validation**
**      ****	**

- Pepe, SM. J Natl Cancer Inst. 2001 Jul 18;93(14):1054-61.

**VALIDATION STRATEGY**

**False Positive Rate**
**False Negative Rate**

**More Stringent Threshold for  Specificity and Sensitivity **

## EDRN Validation Studies 

- The EDRN mandate is to validate markers for:
-  Detection and Early Detection
-  Prognostic markers
-  Risk assessment
- EDRM and Non-EDRN members may submit applications to validate markers

## EDRN Biomarker Validation Studies

**Multi-institutional Studies**

- Protein profiling of prostate cancer using
-     SELDI/MALDI MS
- Detection of early recurrence of bladder cancer
- 	based on detection of Microsatellite Instability (MSA)
- 	in urine exfoliated cells
- 3.	Serum Biomarkers for Hepatocelluar Carcinoma** **

## Communicating with the Scientific Community

**Communicating**** ****with the Scientific Community**

- EDRN Websites, Workshops, Working Group Meetings
- 	Symposia such as the Gordon Research Conference on *New Frontiers in Cancer Detection and Diagnosis*, *January 16-21, 2005 Santa Ynez Valley Marriott Buellton, CA*
- Member Liaisons for relevant professional societies appointed
- Collaborative opportunities published in major journals
- Associate Members
- Scientific publications
- Interaction and collaboration with other NCI programs (e.g., SPORE, PLCP)

## SUMMARY: AN INVESTIGATOR-DRIVEN 

**NETWORK**

- EDRN IS:

-  Interactive and driven by strong science
-  Based on vibrant and efficient collaborations
-  Inclusive (Associate Members and outside collaborations)
-  Dynamic, flexible funding structure
-  Unique infrastructure with resources for translational research