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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00012402 |
Purpose
RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for breast and ovarian cancer.
PURPOSE: Study to determine how screening at different times in the menstrual cycle may affect the results of imaging procedures in women who have a genetic risk of breast or ovarian cancer.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Other: cytology specimen collection procedure Other: physiologic testing Procedure: breast imaging study Procedure: mutation carrier screening Procedure: study of high risk factors |
| Study Type: | Interventional |
| Study Design: | Screening |
| Official Title: | Breast Imaging Studies in Women at High Genetic Risk of Breast Cancer: Menstrual Cycle Pilot Study |
| Study Start Date: | July 2002 |
OBJECTIVES:
OUTLINE:
Menstrual cycle study:
Training cohort study (to train investigators to perform breast duct lavage):
PROJECTED ACCRUAL: Approximately 50 participants (25 BRCA1 or BRCA2 mutation carriers and 25 BRCA1 or BRCA2 mutation non-carriers) will be accrued for the menstrual cycle study, and 25 participants will be accrued for the training cohort study.
Eligibility| Ages Eligible for Study: | 25 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Menstrual cycle study:
Training cohort study (to train investigators to perform breast duct lavage):
All participants:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Menstrual cycle study:
Training cohort study:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Menstrual cycle study:
Other:
Menstrual cycle study:
Training cohort study:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Training cohort study:
Endocrine therapy:
Menstrual cycle study: At least 6 months since prior steroid therapy, selective estrogen receptor modulators, or hormonal agents, including the following:
Training cohort study:
Radiotherapy:
Menstrual cycle study:
Training cohort study:
Surgery:
Menstrual cycle study:
Training cohort study:
Contacts and Locations| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| Principal Investigator: | Jennifer Loud | Clinical Genetics Branch |
More Information
| Study ID Numbers: | CDR0000068533, NCI-01-C-0008 |
| Study First Received: | March 3, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00012402 History of Changes |
| Health Authority: | United States: Federal Government |
|
breast cancer |
|
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |