Clinical trial NCT00897416: Identification of Biomarkers in Women at High Risk or Average Risk of Breast Cancer
Official title: Validation of a Serum Marker Panel for Early Detection of Breast Cancer in High-Risk Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: 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
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 1452
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy women undergoing screening mammography or breast biopsy.

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.

Eligibility 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

Primary outcomes:
measure: Biomarker evaluation for the early detection of breast cancer to improve outcomes for women at risk for breast cancer
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Nicole Urban, ScD
role: PRINCIPAL_INVESTIGATOR
References: