Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00045214 |
RATIONALE: Studying individuals and families at high risk for breast or ovarian cancer may help in identifying the genes involved in the development of breast and ovarian cancer and help to identify other persons at risk for cancer.
PURPOSE: Study to identify genetic, behavioral, and environmental factors related to cancer risk in individuals and families at high risk for breast or ovarian cancer.
Condition | Intervention |
---|---|
Breast Cancer Hereditary Breast/Ovarian Cancer (brca1, brca2) Ovarian Cancer |
Procedure: biopsy Procedure: breast duct lavage Procedure: breast imaging study Procedure: gene mapping Procedure: magnetic resonance imaging Procedure: mammography Procedure: mutation analysis Procedure: questionnaire administration Procedure: study of high risk factors |
Study Type: | Observational |
Official Title: | Study of Clinical, Genetic, Behavioral, Laboratory and Epidemiologic Characterization Of Individuals And Families At High Risk Of Breast/Ovarian Cancer |
Estimated Enrollment: | 500 |
Study Start Date: | June 2002 |
OBJECTIVES:
OUTLINE: Individuals undergo a clinical evaluation that may include a medical history and a physical examination, including possible pelvic or prostate exam. Women may also undergo mammography, MRI of the breast, CA 125 level, transvaginal color doppler, and breast duct lavage. Men may also have a serum PSA obtained if they are over 50 years of age and a breast duct lavage and breast imaging if there is a personal history or risk of familial breast cancer. Some individuals may undergo excisional or needle biopsies or other diagnostic procedures (e.g., galactography or ductal endoscopy) to evaluate a suspected diagnosis of breast, ovarian, or other cancers.
Biologic specimens that may be collected include blood for germline DNA extraction, buccal cells, tumor tissue, and/or skin fibroblasts.
One family member completes a family history questionnaire. Family members may complete psychological assessments.
Some individuals may undergo genetic testing and counseling.
Families are contacted approximately every year for follow-up information.
A certificate of confidentiality protecting the identity of research participants in this project has been issued by the National Cancer Institute.
PROJECTED ACCRUAL: A total of 500 participants will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
DISEASE CHARACTERISTICS:
Any of the following:
Families with a history of any of the following types of syndromes:
Individuals with unusual demographic features, including:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892 | |
Contact: Patient Recruitment 800-518-8474 |
Study Chair: | Mark H. Greene, MD | Clinical Genetics Branch |
Study ID Numbers: | CDR0000256907, NCI-02-C-0212 |
Study First Received: | September 6, 2002 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00045214 |
Health Authority: | Unspecified |
breast cancer hereditary breast/ovarian cancer (BRCA1, BRCA2) male breast cancer ovarian epithelial cancer |
ovarian germ cell tumor borderline ovarian surface epithelial-stromal tumor ovarian sarcoma ovarian stromal cancer |
Ovarian cancer Ovarian Neoplasms Skin Diseases Gonadal Disorders Malignant mesenchymal tumor Genital Neoplasms, Female Breast Neoplasms Endocrine System Diseases Urogenital Neoplasms |
Ovarian Diseases Ovarian epithelial cancer Soft tissue sarcomas Genital Diseases, Female Breast Neoplasms, Male Sarcoma Endocrinopathy Breast Diseases Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Adnexal Diseases |