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

November 5, 2010 updated by: Fred Hutchinson Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1452

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Healthy women undergoing screening mammography or breast biopsy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Estimate)

November 9, 2010

Last Update Submitted That Met QC Criteria

November 5, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5518
  • FHCRC-5518
  • CDR0000355401 (Registry Identifier: PDQ)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe