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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00897416

Enrollment

1452

Registered

2009-05-12

Start date

2001-10-31

Completion date

2007-06-30

Last updated

2010-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

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

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.

Interventions

OTHERlaboratory biomarker analysis

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

25 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Biomarker evaluation for the early detection of breast cancer to improve outcomes for women at risk for breast cancer	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026