Trials / Completed
CompletedNCT00897416
Identification of Biomarkers in Women at High Risk or Average Risk of Breast Cancer
Validation of a Serum Marker Panel for Early Detection of Breast Cancer in High-Risk Women
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,452 (actual)
- Sponsor
- Fred Hutchinson Cancer Center · Academic / Other
- Sex
- Female
- Age
- 25 Years
- Healthy volunteers
- Accepted
Summary
RATIONALE: Collecting and storing samples of blood and studying them in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. PURPOSE: This laboratory study is examining biomarkers in women with a high risk or average risk of breast cancer.
Detailed description
OBJECTIVES: Primary * Identify and validate serum biomarkers that can distinguish malignant from benign and normal breast conditions in women at high risk or average risk for breast cancer. Secondary * Standardize procedures for recruitment, characterization, and follow-up of participants and collection, processing, storage, and analysis of specimens. * Assess marker variability over time in healthy controls. * Develop a shared specimen resource to support ongoing early detection research. OUTLINE: Blood samples are collected every 6 months and assayed for the presence of biomarkers. PROJECTED ACCRUAL: A total of 625 participants will be accrued for this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | laboratory biomarker analysis |
Timeline
- Start date
- 2001-10-01
- Primary completion
- 2007-06-01
- Completion
- 2007-06-01
- First posted
- 2009-05-12
- Last updated
- 2010-11-09
Source: ClinicalTrials.gov record NCT00897416. Inclusion in this directory is not an endorsement.