Study of Ductal Lavage in Women at High Risk for Breast Cancer

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00429988
• Lead Sponsor: University of California, San Francisco

Brief Summary

RATIONALE: Collecting samples of fluid using ductal lavage and nipple aspiration from participants at high risk for breast cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This clinical trial is using ductal lavage to collect fluid from women at high risk for breast cancer.

Detailed Description

OBJECTIVES:

Primary

* Determine the volume of atypical cells collected from ductal lavage in women at increased risk for breast cancer.

Secondary

* Determine assay techniques to analyze nipple aspirate fluid and ductal lavage fluid samples from these participants.

* Analyze the nipple aspirate fluid from these participants for specific and global protein signatures.

* Determine the replicability of markers in serial assays of these participants.

* Determine the percentage of participants with atypia on ductal lavage in which ductal lesions can be identified using ductoscopy.

OUTLINE: This is a multicenter study.

Participants undergo nipple aspirate fluid and ductal lavage fluid collection. Fluid samples are analyzed using cytological analysis, immunohistochemistry, fluorescent in situ hybridization, or in situ polymerase chain reaction. Protein patterns are identified using mass spectrometry.

Participants found to have atypia undergo repeat lavage at 3-6 months and 1 year. Participants with normal fluid samples undergo repeat lavage at 1 year.

PROJECTED ACCRUAL: A total of 30 participants will accrued for this study within 2-3 months.

Study Timeline

• Study Start: 2002-08
• Primary Completion: 2004-06
• Study Completion: 2004-06
• Study First Submitted: 2007-01-30
• Study First Submitted QC: 2007-01-30
• Study First Posted: 2007-02-01
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-25
• Last Update Posted: 2012-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Average number of atypical cells per ductal lavage sample

Secondary Outcome Measures

Name	Time	Method
Assay techniques development for nipple aspirate fluid and ductal lavage fluid analysis
Specific and global protein signature analysis of nipple aspirate
Replicability of markers in serial assays
Percentage of participants with atypia on ductal lavage in which ductal lesions can be identified using ductoscopy

Trial Locations

Locations (1)

UCSF Comprehensive Cancer Center; 🇺🇸 San Francisco, California, United States