InterSPORE Prostate Biomarker StudyIPBS - PowerPoint PPT Presentation
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Title: 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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(No Transcript)
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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
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