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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00897416
• Other study ID #: 5518
• Secondary ID: FHCRC-5518CDR000
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: November 5, 2010
• Start date: October 2001
• Est. completion date: June 2007

Study information

• Verified date: November 2010
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1452
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarker evaluation for the early detection of breast cancer to improve outcomes for women at risk for breast cancer			No