Expired Study
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Bethesda, Maryland 20892


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.


Study summary:

OBJECTIVES: - Determine the effect of menstrual cycle on five breast imaging methods and any differences in these imaging results between women who are BRCA1 or BRCA2 mutation carriers and non-carriers. - Assess the use of breast duct lavage to obtain epithelial cell samples for cytologic evaluation and molecular/genetic studies in women with BRCA1 or BRCA2 mutations. - Compare breast duct lavage cytologies from asymptomatic premenopausal BRCA1 or BRCA2 mutation carriers and non-carriers to assess whether the results vary with menstrual cycle timing. OUTLINE: Menstrual cycle study: - Participants undergo a physical exam, including the breast and pelvis, standard four-view mammogram, and breast magnetic resonance imaging scan during either the early follicular phase or the mid-luteal phase of the menstrual cycle. Participants also undergo a CA 125 level determination and transvaginal color doppler ultrasonography. Three months later, participants undergo a unilateral cranio-caudal mammogram and bilateral MRI during the menstrual cycle phase not previously studied. All participants undergo breast duct lavage at each study visit. Repeat screening studies are performed annually for 3 years. - Participants are followed annually. Training cohort study (to train investigators to perform breast duct lavage): - Volunteers undergo cancer risk assessment and nipple aspiration. Breast duct lavage may be performed on participants who express nipple aspiration fluid. Results are sent to the participant and her physician. Participants with atypical cytologies are contacted individually, and an appropriate follow-up plan is made in coordination with her physician. 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.


Criteria:

DISEASE CHARACTERISTICS: Menstrual cycle study: - Known carrier of BRCA1 or BRCA2 mutation OR - First- or second-degree relative of an individual with a tumor associated with Breast-Ovarian Cancer Syndrome in a family with a known BRCA mutation - Have undergone genetic counseling and risk assessment - Normal CA 125 levels - No menstrual cycle irregularities within the previous 6 months - No history of ductal carcinoma in situ or lobular carcinoma in situ Training cohort study (to train investigators to perform breast duct lavage): - Volunteers who had a mammogram within the past 12 months showing low or no suspicion of carcinoma in at least 1 breast - Prior physical examination of the breast showing low or no suspicion of carcinoma All participants: - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - Menstrual cycle study: - 25 (or 5 years younger than the age at diagnosis of the youngest family member with a tumor associated with Breast-Ovarian Cancer Syndrome) to 45 - Training cohort study: - 18 to 50 Sex: - Female Menopausal status: - Premenopausal Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Menstrual cycle study: - Creatinine less than 2 mg/dL Other: - Menstrual cycle study: - No history of invasive cancer except non-melanoma skin cancer or carcinoma in situ of the cervix - No infertility with suspected ovarian etiology or persistent ovarian cysts - Not pregnant or nursing within past 12 months - No history of diabetes - No known allergy to gadolinium, lidocaine, or bupivacaine - No medical or psychiatric disorder that would preclude study - Fasting blood glucose normal - Weight no greater than 136 kg (299 lbs) - Fertile patients must use non-hormonal contraception - Agree to release results of genetic test for stratification purposes - Training cohort study: - Not pregnant or nursing within the past 12 months - No active infection or inflammation in breast to be studied - No known allergy to lidocaine, prilocaine, or bupivacaine PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Training cohort study: - At least 12 months since prior chemotherapy Endocrine therapy: - Menstrual cycle study: At least 6 months since prior steroid therapy, selective estrogen receptor modulators, or hormonal agents, including the following: - Tamoxifen - Raloxifene - Estrogen - DHEA - Anabolic steroids - Oral contraceptives - Depoprovera - Progestin IUD - Oral progestins - Norplant - Drugs to induce ovulation - Training cohort study: - At least 12 months since prior selective estrogen receptor modulators, including tamoxifen and raloxifene Radiotherapy: - Menstrual cycle study: - No prior bilateral radiotherapy - Training cohort study: - No prior radiotherapy to breast to be studied Surgery: - Menstrual cycle study: - No bilateral mastectomy or oophorectomy - Training cohort study: - No breast implant or prior silicone injections in breast to be studied - No prior subareolar or other surgery to the breast to be studied (biopsy or fine-needle aspiration at least 2 cm from the nipple allowed)


NCT ID:

NCT00012402


Primary Contact:

Principal Investigator
Jennifer Loud
Clinical Genetics Branch


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

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