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

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

Fred Hutchinson Cancer Research Center

ClinicalTrials.gov Identifier:

NCT00897416

First received: May 9, 2009

Last updated: November 5, 2010

Last verified: November 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

May 9, 2009

Last Updated Date

November 5, 2010

Start Date ^ICMJE

October 2001

Primary Completion Date

June 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Biomarker evaluation for the early detection of breast cancer to improve outcomes for women at risk for breast cancer [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00897416 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Healthy women undergoing screening mammography or breast biopsy.

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Other: laboratory biomarker analysis

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1452

Completion Date

June 2007

Primary Completion Date

June 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

25 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00897416

Other Study ID Numbers ^ICMJE

5518, FHCRC-5518, CDR0000355401

Has Data Monitoring Committee

Not Provided

Responsible Party

Nicole Urban, ScD, Fred Hutchinson Cancer Research Center

Study Sponsor ^ICMJE

Fred Hutchinson Cancer Research Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

Nicole Urban, ScD

Fred Hutchinson Cancer Research Center

Information Provided By

Fred Hutchinson Cancer Research Center

Verification Date

November 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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