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NCT00006425 · ClinicalTrials.gov registry record
Breast Imaging Studies in Women at High Genetic Risk of Breast Cancer: Menstrual Cycle Study
A clinical trial, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- 20
- Enrollment target
NCT00006425: Completed study, sponsored by National Cancer Institute (NCI).
NCT00006425 is a clinical trial that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00006425 has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- 20 participants
- Enrollment target
Study Summary
Women who carrying a BRCA1 or BRCA2 gene mutation or who are the first- or second-degree relative of an individual with a BRCA-associated cancer in a family documented to have a BRCA1 or BRCA2 mutation will be eligible for enrollment into this pilot study of breast cancer screening modalities. We will recruit up to fifty women (twenty-five women who carry an altered BRCA1 or BRCA2 gene and 25 non-carriers matched by age and family mutation type) with regular menstrual cycling (documented by menstrual history and premenopausal FSH level). A physical exam including exam of the breast and pelvis, a standard four view mammogram, breast MRI and PET scan will be scheduled initially during either the follicular or mid-luteal phase of the menstrual cycle. A unilateral cranio-caudal mammogram, and bilateral MRI and PET scan will be repeated three months after entry during the phase not initially studied. A CA125 and transvaginal color doppler ultrasonography will be done in the follicular phase. Carriers and non-carriers will be compared with respect to menstrual cycle differences in: (1) two measures of mammographic density (qualitative and semiquantitative); (2) a semiquantitative measure of fibroglandular volume (MRI); (3) a semiquantitative measure of contrast enhancement (MRI); and (4) FDG uptake measured over time (PET scan). On the initial and three-month visit, all participants will undergo breast duct lavage to investigate if there are consistent menstrual cycle differences in breast ductal cytologies. Participants will be seen annually thereafter for an additional three years of follow-up. A physical exam, standard four-view mammography, breast MRI, CA 125, transvaginal color doppler ultrasonography and breast duct lavage will be done annually. Consent for a PET study will be requested if an abnormality is detected on mammography or breast MRI requiring additional clinical or radiographic follow-up. Participants in the Menstrual Cycle Pilot Study, will complete a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2000-12-19 |
| Est. Completion | 2008-10-03 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00006425
The ClinicalTrials.gov registry entry for NCT00006425 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00006425 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00006425 about?
NCT00006425 is a clinical study titled "Breast Imaging Studies in Women at High Genetic Risk of Breast Cancer: Menstrual Cycle Study". Women who carrying a BRCA1 or BRCA2 gene mutation or who are the first- or second-degree relative of an individual with a BRCA-associated cancer in a family documented to have a BRCA1 or BRCA2 mutation will be eligible for enrollment into this pilot study of breast cancer screening modalities. We wi...
What is the current status of trial NCT00006425?
This trial is currently completed. The enrollment target is 20 participants. The study started on 2000-12-19. Estimated completion is 2008-10-03.
Who is sponsoring clinical trial NCT00006425?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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