NCT00081003

Nipple Aspiration, Ductal Lavage, and Duct Endoscopy in Screening Women at Moderate-to-High Risk of Developing Breast Cancer

The Intraduct Environment: A Novel Approach to Risk Assessment of Women With a Family History of Breast Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Royal Marsden NHS Foundation Trust · Academic / Other
• Sex: Female
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
GENETIC	gene expression analysis
GENETIC	protein expression analysis
OTHER	cytology specimen collection procedure
OTHER	laboratory biomarker analysis
OTHER	physiologic testing
PROCEDURE	breast duct lavage
PROCEDURE	endoscopic biopsy
PROCEDURE	study of high risk factors

Timeline

• Start date: 2003-11-01
• First posted: 2004-04-08
• Last updated: 2014-07-23

Locations

1 site across 1 country: United Kingdom