Identification of Biomarkers in Women at High Risk or Average Risk of Breast Cancer
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ClinicalTrials.gov Identifier: NCT00897416 |
Recruitment Status
:
Completed
First Posted
: May 12, 2009
Last Update Posted
: November 9, 2010
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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.
Condition or disease | Intervention/treatment |
---|---|
Breast Cancer | Other: laboratory biomarker analysis |
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 |
Actual Enrollment : | 1452 participants |
Time Perspective: | Prospective |
Official Title: | Validation of a Serum Marker Panel for Early Detection of Breast Cancer in High-Risk Women |
Study Start Date : | October 2001 |
Actual Primary Completion Date : | June 2007 |
Actual Study Completion Date : | June 2007 |

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

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Ages Eligible for Study: | 25 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00897416
Principal Investigator: | Nicole Urban, ScD | Fred Hutchinson Cancer Research Center |
Responsible Party: | Nicole Urban, ScD, Fred Hutchinson Cancer Research Center |
ClinicalTrials.gov Identifier: | NCT00897416 History of Changes |
Other Study ID Numbers: |
5518 FHCRC-5518 CDR0000355401 ( Registry Identifier: PDQ ) |
First Posted: | May 12, 2009 Key Record Dates |
Last Update Posted: | November 9, 2010 |
Last Verified: | November 2010 |
Keywords provided by Fred Hutchinson Cancer Research Center:
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 |
Additional relevant MeSH terms:
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |