Identification of Biomarkers in Women at High Risk or Average Risk of Breast Cancer

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00897416
• Lead Sponsor: Fred Hutchinson Cancer Center

Brief 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.

Study Timeline

• Study Start: 2001-10
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-05
• Last Update Posted: 2010-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1452

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biomarker evaluation for the early detection of breast cancer to improve outcomes for women at risk for breast cancer