Completed

Breast Imaging Studies in Women at High Genetic Risk of Breast Cancer: Annual Follow-Up Study

Breast Imaging Screening Studies in Women at High Genetic Risk of Breast Cancer: Annual Follow-up Study

Sponsor
National Cancer Institute (NCI) (NIH)
Enrolment
200 enrolled
Conditions
Breast Cancer
Interventions
2-Fluorodeoxyglucose
Ages
adults, older adults
Registry
NCT00006421

From the registry

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…

Primary outcomes

  • Differences in measures of mammographic density and MRI fibroglandular volume between mutation positive and mutation negative women
  • Cytologic cell counts, mammographic density and MRI fibroglandular volume
  • Obtain biologic materials in participants who undergo clinically indicated surgical procedures and NAF/BDL over time and correlate with outcomes of breast screening.
  • Use questionnaires and interviews to evaluate the impact, emotional outcomes and decision-making in study participants
Full record on ClinicalTrials.gov