Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-24 @ 7:22 PM
NCT ID:
NCT00081003
Brief Summary:
RATIONALE: Screening tests, such as nipple aspiration, ductal lavage, and breast duct endoscopy, may help doctors detect cancer cells early and plan more effective treatment for breast cancer.
PURPOSE: This clinical trial is studying how well nipple aspiration, ductal lavage, and breast duct endoscopy work in detecting cancer cells in healthy women who are at moderate-to-high risk of developing breast cancer.
Detailed Description:
OBJECTIVES:
Primary
* Determine the incidence of mild or severe cellular atypia in nipple aspirate fluid of healthy women at moderate to high risk of developing breast cancer, defined by family history or prior atypical biopsy.
Secondary
* Correlate cellular atypia with breast cancer, biochemical tumor markers, growth factors, and genetic and protein markers in these participants.
* Determine cancer risk and incidence utilizing these methods of screening in these participants.
* Observe the natural history of atypia in these participants over a total of 10 years.
* Determine whether these techniques may serve as supplementary tools in future screening of these participants.
OUTLINE: Participants under 50 years of age undergo nipple aspiration every twelve months for 3 years. Participants over 50 years of age undergo nipple aspiration every 18 months for 4.5 years.
Participants with significant cellular atypia in nipple aspirate fluid undergo ductal lavage and endoscopy.
Participants are followed annually for a total of 10 years.
PROJECTED ACCRUAL: A total of 1,000 participants will be accrued for this study within approximately 4 years.
Study:
NCT00081003
Study Brief:
Protocol Section:
NCT00081003