InterSPORE Prostate Biomarker StudyIPBS

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Inter-SPORE Prostate Biomarker Study(IPBS) caBIG

• Johns Hopkins
• Baylor
• MSKCC
• University Michigan
• Dana Farber
• NorthWestern

MD Anderson UCSF Fred Hutch UCLA Mayo
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What is IPBS?

• Inter-SPORE Prostate Biomarker Study
• Exchange Biospecimens Between SPOREs
• Retrospective Arm
• Samples in Hand
• Limited to Data Previously Collected
• Prospective Arm
• New Accruals
• Each Biomarker lab test a marker using
  Biospecimens collected across all SPOREs

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What is Its Purpose?

• Most Biomarkers Not Reproducible.
• Biomarkers that appear biomedically and
  statistically significant at one center turn out
  NOT to be significant in other centers.
• RESPONSE
• 11 Prostate SPORES Exchange Samples, Test
  Biomarkers (a Unique Study)

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Why Is It Important?

• The IPBS itself is a timely, critically
  important, ground-breaking study.
• It is widely recognized that other, similar
  studies are essential. Thus, IPBS has been
  looked at as a prototype that will help create a
  path towards making these other studies possible
  and efficient (remember the NBN?).
• Data sharing is a Critical Component of IPBS.
• The "G" in caBIG stands for Grid. It is
  essential that the caBIG tools, and the sharing
  (Grid) components in particular, receive
  real-world, "live ammo" testing.

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IPBS Prospective Study Outline
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IPBS Prospective Study IT Needs

• Need something better then email and spreadsheets
  to coordinate a multi-center biomarker study.
• Need mechanism to facilitate requirements
  gathering and consensus building -- a straw man.
• Need to get something going fast.
• Need a flexible framework to accommodate several
  rounds of changes.
• Need to track the movement of samples.
• Need someone willing to do the work, host and
  support a short-term solution.

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IPBS Prospective Informatics needs and caTissue
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Engineering Strategy 1
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Engineering Strategy 2
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What are the Requirements?

• Multi-center prospective biomarker study.
• 200 data elements.
• Some related to study management (Protocol Data).
• Some perhaps only relevant to this study.
• Three distinct workflows.
• Eight Case Report Forms.
• Different people collecting different data at
  different point of interaction with patients.

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Three Workflows
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Eight CRFs

• Accrual Form Details
• Patient Questionnaire
• Quality of Life
• Patient Data from Chart
• Tissue Collection
• Serum Collection
• Procedure Pathology Form
• Follow-up (including QoL again)

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Engineering Strategy 3
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Short-term solution- pTracker
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pTracker - Patient Accrual
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Demographics form
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pTracker caTissue Suite

• Periodically export data (to XML) from pTracker
  and import into each caTissue instance.

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Need to Extend caTissue

• Some IPBS data elements In-Scope are NOT in
  caTissue Core, CAE.
• REQUIREMENT Need to be able to add many CDEs to
  caTissue Core, CAE.
• This is a significant task!
• Plan
• Extend caTissue Suite via Dynamic Addition of
  CDEs or extend the object model to accommodate
  new attributes.
• Work closely with caTissue Suite Developers.

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Nature of Our Task SOW Details

• Formally Define Task
• Do a GAP Analysis
• Use Cases
• Software Requirement Specification
• Develop a Deployment Plan for caTissue Suite to
  support a Federation of instances.
• Develop CDEs
• Unique to IPBS
• Decided what is In/out of Scope
• Use caTissue Suite Tools (DE) to Add CDEs
• Submit to EVS
• Migrate Data already collected via short-term
  solution into caTissue Suite
• Test and Report

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Nature of Our Task Overview
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Federated Use Cases

• Distributed querying across a Federation.
• Biospecimen Request across a Federation.
• Request Review / Approval where request
  originates from External Member of Federation.
• Request confirmation.
• Shipping of biospecimens.
• Biospecimen Receiving.
• Creating common collection protocols across
  institutions
• Saving query parameters for a federated query
• Saving query results from a federated query

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Contact Info

• Buddy Dennis (rdennis_at_mednet.ucla.edu)
• IPBS Short-term solutions http//staging.ctrl.ucla
  .edu8181/
• Use Case Document - https//gforge.nci.nih.gov/pro
  jects/spores/
• Look under Documents Tab