# Presentation: 226602

## Update of IPBSData Elements

**Samson W. Fine, MD**
**Department of Pathology                                                                                                                  Memorial Sloan Kettering Cancer Center**

## Objectives for Data Elements

**Develop a system for information and specimen sharing to enable and facilitate biomarker research**
**Adopt a common unifying language for data elements to encompass all participants **

## The Challenges

**Few medical centers / SPORE sites have  demographic, clinical, procedural, processing, and pathology data in one location **
**Multiple (?competing) systems **
**There is no current standardized reporting**** **

## The Ultimate Challenge

**For a large project such as the IPBS: **
**  **
**   ****How do we connect multiple institutions with multiple systems in an environment where terminology and data is not uniformly recorded?**** **

## The Ultimate Challenge

**For a large project such as the IPBS:   **
**   ****How do we connect multiple institutions with multiple systems in an environment where terminology and data is not uniformly recorded?**** **

**ESSENTIAL DATA ELEMENTS**

## IPBS Data Elements

**Demographics / Epidemiology (n=28)**
**Medical History (n=5)**
**Clinical (n=20)**
**Pathology (n=13)**
**Clinical Follow-up (n=29)**
**Blood / Urine Specimen Follow-up (n=36)**

## Pathology Data Elements:          Lessons Learned

- DATA ELEMENTS ARE ONLY DATA ELEMENTS IF SEEN THROUGH                THE EYES OF THE BEHOLDER
- Urologists
- Radiation Oncologists
- Oncologists
- Laboratory Medicine
- Anatomic Pathologists

## Pathology Data Elements:  Lessons Learned

- Teamwork
- SPORE site designees
- BCM, DFCI, FHCRC/UW, JHU, MAYO, MDACC, MSKCC, NWU, UCLA, UCSF, UMICH
- Point person
- Communicate to all
- Collect and collate reports / data elements
- Formulate “comparative language” document
- Re-circulate for approval
- Adoption of “Essential Data Elements”

## RP Data Elements

- Histologic Type of PCa			8
- Primary Gleason grade 		11
- Secondary Gleason grade 		11
- Total Gleason score 			11
- Tertiary Gleason grade 		7
- Volume of Gleason pattern 4/5		1
- Prostate volume +/- weight		5
- Tumor volume 			4
- Tumor extent (min/mod/ext)		1
- Tumor size 			5
- Location of tumor			11
- Tumor multicentricity 			11
- Number of cancer foci			1
- Zone of cancer			4
- Number of cancer foci per zone		1
- Tumor volume per zone		1
- Location of  “dominant” focus		8
- Size/vol of “dominant” focus		3
- Zone/gr/st/marg of each focus		4

- Extraprostatic extension (yes/no) 		11
- Location/Extent of extraprostatic extension	10
- Capsular involvement 			4
- Seminal vesicle invasion		11
- Margin status (positive/negative)		11
- Margin location (if positive)		11
- Total number of lymph nodes dissected	10
- Number of positive lymph nodes		10
- Dimension of largest positive node	3
- Extranodal extension			3
- pT					7
- pN					6
- pM					4
- AJCC 1992				1
- AJCC 1997				2
- AJCC 2002				3
- Other staging system(s)		1
- Perineural invasion 			4
- Vascular/venous/lymphatic invasion	4
- Apex involvement			3
- Bladder neck involvement		5
- Benign glands at the margin		3
- High grade PIN			8
- Inflammation			2
- Benign prostatic hypertrophy		3

**# of sites reporting**

## Comparative Language

**Comparative Language**

## Essential Pathology Data Elements

**Tumor Grade:**
- 	Primary Gleason grade (most common)
- 	Secondary Gleason grade (second most common)
- 	Total Gleason score (primary + secondary grades)
- 	Tertiary Gleason grade (when present)
**Tumor Stage/Extent:**
- 	Location of tumor (right/left, anterior/posterior, apex/mid/base)
- 	Extraprostatic extension (yes/no)
- 	Location/Extent of extraprostatic extension
- 	Seminal vesicle invasion (yes/no)
- 	Margin status (positive/negative)
- 	Margin location (if positive)
- 	Total # of lymph nodes dissected
- 	# of positive lymph nodes
**Pre-neoplastic conditions:**
-          High grade prostatic intraepithelial neoplasia (PIN)

## Easy: “Seminal Vesicle Invasion”

| Seminal vesicle invasion |
| --- |
| Seminal vesicle involvement |
| Seminal vesicle involvement |
| Seminal vesicle invasion |
| Seminal vesicles |
| Pathologic Stage |
| Seminal vesicles |
| Seminal vesicles |
| Seminal vesicles |
| Involvement of seminal vesicle |
| SVI (seminal vesicle status) |

## More Complex:                “Extraprostatic Extension”

| Extracapsular extension |
| --- |
| Extraprostatic soft tissue involvement |
| Tumor does/not invade periprostatic fibroadipose tissue |
| Local extent (OC/EPE) |
| Extraprostatic extension into periprostatic soft tissue |
| OC / MOR+,EPE- / EPE+,MOR+ or - |
| Capsule (OC/IBNB/FECE/EECE) |
| Extraprostatic extension (in fat) |
| Capsular involvement (None/IBNB/penetrates thru capsule) |
| Involvement of capsule / extraprostatic extension |
| EPE |

## Why is there variability in reporting?

**Why is there variability in reporting?**

## Difficult: “Location of Tumor”

| Location/Zone (Index Cancer/Accessory#1/Accessory#2) |
| --- |
| Cancer present on left / right |
| Unilateral/bilateral (if multiple tumors – report loc. of each) |
| Location (L/R; A/L/PL/P; A/M/B) dominant / secondary nodule  |
| Involving the prostate – site; R/L |
| Zonal origin of CA foci |
| Tumor location – dominant tumor mass is located in  |
| Involvement (R/L); Location main tumor / additional nodules  |
| Location of tumor (L/Mid/R; A/P; A/B) |
| Location of tumor |
| Multifocal/Pztumor_rm/Pztumor_ra/Pztumor_lm/Pztumor_la/ Tz tumor |

## Moving Forward

- Presuming all data elements undergo similar collection, collation, linking, and vetting
- All institutions would agree to release tissue
- WE HAVE STILL NOT ENROLLED A PATIENT

## What Data is Necessary for a      Minimum IPBS Database

- Tracking of accruals
- List of patients enrolled
- Per institution
- Patient identifier
- Date of enrollment
- Date of prostate biopsy
- Nomogram score

## Tracking specimens
Per biopsy slide shipment (e-copy / paper)
All clinical history EDE prior to biopsy
Prostate biopsy pathology report EDE for shipped slides 
Institution 
Patient identifier
Date of prostate biopsy
# slides sent
Shipping date / person who sent it /                              date received / person receiving / sample intact?
Carrier / tracking number
Location of cores shipped

- Per biopsy slide shipment (e-copy / paper)
- All clinical history EDE prior to biopsy
- Prostate biopsy pathology report EDE for shipped slides
- Institution
- Patient identifier
- Date of prostate biopsy
- # slides sent
- Shipping date / person who sent it /                              date received / person receiving / sample intact?
- Carrier / tracking number
- Location of cores shipped

**What Data is Necessary for a      Minimum IPBS Database**

## Tracking specimens
Per serum shipment (e-copy / paper)
Institution 
Patient identifier
Date(s) of sample(s)
# tubes sent
Shipping date / person who sent it /                              date received / person receiving / sample intact?
Carrier / tracking number

MOCK EXCHANGE – THE “LEGO” TEST

- Per serum shipment (e-copy / paper)
- Institution
- Patient identifier
- Date(s) of sample(s)
- # tubes sent
- Shipping date / person who sent it /                              date received / person receiving / sample intact?
- Carrier / tracking number
- MOCK EXCHANGE – THE “LEGO” TEST

**What Data is Necessary for a      Minimum IPBS Database**