Update of IPBS Data Elements

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Update of IPBSData Elements
Samson W. Fine, MD Department of Pathology


Memorial Sloan Kettering Cancer Center
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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

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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

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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?

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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
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IPBS Data Elements

• Demographics / Epidemiology (n28)
• Medical History (n5)
• Clinical (n20)
• Pathology (n13)
• Clinical Follow-up (n29)
• Blood / Urine Specimen Follow-up (n36)

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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

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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

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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

of sites reporting
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Comparative Language
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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)

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Easy Seminal Vesicle Invasion
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More Complex Extraprostatic
Extension
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Why is there variability in reporting?
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Difficult Location of Tumor
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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

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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

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What Data is Necessary for a Minimum IPBS
Database

• 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

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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