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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Validation of a Serum Marker Panel for Early Detection of Breast Cancer in High-Risk Women

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Planning to undergo outpatient annual mammogram or biopsy AND meets 1 of the following criteria: High risk for breast cancer High risk with newly-diagnosed* breast cancer Average risk for breast cancer Average risk with newly-diagnosed* breast cancer Benign breast disease NOTE: * Diagnosed at time of study enrollment No other breast cancer diagnosis within the past year Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age 25 and over Sex Female Menopausal status Not specified Performance status Not specified Life expectancy Not specified Hematopoietic No hemophilia No other bleeding disorders Hepatic Not specified Renal Not specified Other Not pregnant or nursing At least 6 months postpartum No planned pregnancy within the next year No history of medical conditions that would increase participant risk of blood draws No psychiatric, psychological, or other condition that would preclude giving informed consent PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery No prior double mastectomy Other No concurrent treatment for breast cancer

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: laboratory biomarker analysis|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker evaluation for the early detection of breast cancer to improve outcomes for women at risk for breast cancer |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer