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WHI biospecimen data. Bernedine Lund/Sue Mann 5/6/09. Planning for biospecimen use. Specimen collection protocol. Baseline—All participants Serum Plasma (citrate & EDTA) Buffy coat Red blood cells Urine (BMD subsample—3 sites only) Follow-up: Blood

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whi biospecimen data

WHI biospecimen data

Bernedine Lund/Sue Mann

5/6/09

specimen collection protocol
Specimen collection protocol
  • Baseline—All participants
    • Serum
    • Plasma (citrate & EDTA)
    • Buffy coat
    • Red blood cells
    • Urine (BMD subsample—3 sites only)
  • Follow-up: Blood
    • CT: 100% year 1, 6% years 3,6,9 (no DNA)
    • OS: 100% year 3
  • Follow-up: Urine
    • BMD subsample: 100% years 1,3,6,9 (no blood)
  • Details: www.whiscience.org/about/biospecimen.php
blood collection and storage data

Blood collection and storage data

Blood sample number

Status of Participant

Hours since last ate

Vigorous activity in previous 8 hours

Aspirin or NSAID in previous 48 hours

Blood processing data

Time drawn

Time centrifuged

Time aliquoted

Time frozen

Number of freeze/thaw cycles

sources of biospecimen data
Sources of biospecimen data
  • CBC done by local labs on 100% of participants
    • CT/OS WBC, hematocrit, and platelet count at baseline [for eligibility assessment, NOT core analytes]
    • OS WBC at Year 3
  • Core analytes
    • Measured on 6% CT cohort, ~1% sample of OS
    • Analytes include micronutrients, lipid profile, clotting factors, insulin, glucose
  • Details: www.whiscience.org/about/biospecimen.php
other sources of biospecimen data completed whi studies
Other sources of biospecimen data:Completed WHI studies
  • Core studies
  • Ancillary studies
  • BAA studies
  • Collaborative studies
whi policy for biospecimen data
WHI policy for biospecimen data
  • All data derived from WHI biospecimens must be provided to the CCC.
  • All WHI investigators will have rights to use these data in accordance with WHI publications and ancillary study policies.
accessing biospecimen data
Accessing biospecimen data
  • Data derived from WHI (core) funds
    • Policy for access is the same as all other WHI data
    • Only CBC currently available on the website
  • Data derived from ancillary or BAA studies
    • Access to data protected until first publication or end of the funding period
    • WHI actively encourages collaboration with the AS/BAA PI
summary blood assay reports available on web sites
Summary blood assay reportsavailable on Web sites
  • Web Sites
    • WHI Science: Funded studies
    • WHI Study Operations: Funded and approved (not yet funded) studies
  • Key WHI Science Reports
    • Funded Studies
    • Studies Using Blood Specimen by Outcome
    • Assays by Outcome
    • Assays by Study
funded studies http www whiscience org ancillary ancillary studies funded pdf
Funded Studieshttp://www.whiscience.org/ancillary/ancillary_studies_funded.pdf
slide11

2. Biospecimen Use by Outcome for Funded Studies

http://www.whiscience.org/ancillary/biospecimen_by_oc_funded.pdf

3 assays by outcome http www whiscience org ancillary serum by oc funded pdf
3. Assays by Outcomehttp://www.whiscience.org/ancillary/serum_by_oc_funded.pdf
4 assays by study http www whiscience org ancillary serum by study funded pdf
4. Assays by Studyhttp://www.whiscience.org/ancillary/serum_by_study_funded.pdf
blood assay information collected

Blood assay information collected

Assay name

Units

Type of specimen

Lab name

Assay method (if available)

Version number of assay

A change in any of the items above leads to a change in the version number.

some complexities of using existing biomarker data
Some complexities of using existing biomarker data
  • Nothing is available on everyone
  • Each study designed for specific goal
    • Cases and controls are not representative of the WHI population
  • Labs and/or methods may vary from one study to another
  • Pulling biomarker data from multiple unrelated studies not recommended
biospecimen use process
Biospecimen Use Process

Upon Approval and Funding:

Data Ops and Stat Unit Representatives Meet

Investigator Completes a Biospecimen & Participants Questionnaire

CCC hosts kick off conference call

Stat Unit selects participants

Data Ops Unit finalizes the biospecimen details and asks the investigator to ‘sign off’ on the “facts“

Database Unit creates the sample pulls and coordinates the processing and shipping

just call me
Just call me…
  • Sue Mann
  • Data Operations Manager
  • Women’s Health Initiative
  • 206-667-2869
  • smann@whi.org