Identification of Biomarkers in Women at High Risk or Average Risk of Breast Cancer
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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Biomarker evaluation for the early detection of breast cancer to improve outcomes for women at risk for breast cancer
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .