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NCT00006421 · ClinicalTrials.gov registry record
Breast Imaging Studies in Women at High Genetic Risk of Breast Cancer: Annual Follow-Up Study
A clinical trial, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- 200
- Enrollment target
NCT00006421: Completed study, sponsored by National Cancer Institute (NCI).
NCT00006421 is a clinical trial that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 200 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00006421 has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- 200 participants
- Enrollment target
Study Summary
This study will explore new screening methods for early detection of breast and ovarian cancer in women at high risk for these diseases, because they have an altered breast cancer 1 (BRCA1) or breast cancer 2 (BRCA2) gene. It will also try to determine if breast tissue characteristics in women with a BRCA1 or BRCA2 mutation differ from those in women with a normal gene. Premenopausal women between 25 and 45 years of age who have participated in National Cancer Institute studies for families or individuals at high genetic risk of cancer (78-C-0039 or 99-C-0081) and who have at least a 50 percent probability of carrying an altered BRCA1 or BRCA2 gene may be eligible for this study. At the first visit, participants will have from 4 to 24 tablespoons of blood drawn and will be interviewed about breast and ovarian cancer risk factors, family and personal history of cancer, history of pregnancies, use of oral contraceptives and other hormones and drugs, and previous surgery on the breasts and ovaries. In addition, they will undergo the following procedures: Routine breast and ovarian cancer screening for high-risk women, including a mammogram, breast and pelvic exam, instruction in breast self-examination, CA 125 blood test and transvaginal ultrasound of the ovaries. Magnetic Resonance Imaging (MRI) of the breast MRI uses a strong magnetic field to show structural and chemical changes in tissues. Breast Duct Lavage In this procedure samples of fluid and cells from the lining of the breast milk ducts are collected to look for cancerous or pre-cancerous cell changes. Positron Emission Tomography (PET) scan PET scanning will be done only in participants whose mammogram or MRI findings require additional evaluation. This diagnostic test is based on differences in how cells take up and use glucose (sugar), one of the body s main fuels. Annual follow-up visits will be scheduled for 3 years and will include routine high-risk screening as described above, blood draw, updat
Primary Outcome
Compare four outcomes including two mammographic density measures (qualitative and semi-quantitative), fibroglandular volume measure using MRI, and contrast enhancement measure using MRI (both semiquantitative) in mutation carriers/non-carriers to improve lesion detection
Interventions
- DRUG 2-Fluorodeoxyglucose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2000-10-25 |
What the finished NCT00006421 record still lists
NCT00006421 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which 2-Fluorodeoxyglucose is the first listed.
NCT00006421 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00006421 about?
NCT00006421 is a clinical study titled "Breast Imaging Studies in Women at High Genetic Risk of Breast Cancer: Annual Follow-Up Study". This study will explore new screening methods for early detection of breast and ovarian cancer in women at high risk for these diseases, because they have an altered breast cancer 1 (BRCA1) or breast cancer 2 (BRCA2) gene. It will also try to determine if breast tissue characteristics in women with ...
What is the current status of trial NCT00006421?
This trial is currently completed. The enrollment target is 200 participants. The study started on 2000-10-25.
What interventions are being tested in trial NCT00006421?
The interventions under investigation include: 2-Fluorodeoxyglucose (DRUG).
Who is sponsoring clinical trial NCT00006421?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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