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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1452 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-10-31

Study Completion Date

2007-06-30

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.

Conditions

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Breast Cancer

Keywords

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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

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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laboratory biomarker analysis

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Fred Hutchinson Cancer Research Center

Principal Investigators

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Nicole Urban, ScD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Other Identifiers

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FHCRC-5518

Identifier Type: -

Identifier Source: secondary_id

CDR0000355401

Identifier Type: REGISTRY