Study of Ductal Lavage in Women at High Risk for Breast Cancer
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.
Genetic: fluorescence in situ hybridization
Genetic: polymerase chain reaction
Genetic: proteomic profiling
Other: cytology specimen collection procedure
Other: immunohistochemistry staining method
Procedure: breast duct lavage
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Ductal Lavage to Monitor and Treat High Risk Women|
- Average number of atypical cells per ductal lavage sample [ Designated as safety issue: No ]
- Assay techniques development for nipple aspirate fluid and ductal lavage fluid analysis [ Designated as safety issue: No ]
- Specific and global protein signature analysis of nipple aspirate [ Designated as safety issue: No ]
- Replicability of markers in serial assays [ Designated as safety issue: No ]
- Percentage of participants with atypia on ductal lavage in which ductal lesions can be identified using ductoscopy [ Designated as safety issue: No ]
|Study Start Date:||August 2002|
|Study Completion Date:||June 2004|
|Primary Completion Date:||June 2004 (Final data collection date for primary outcome measure)|
- Determine the volume of atypical cells collected from ductal lavage in women at increased risk for breast cancer.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00429988
|United States, California|
|UCSF Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|Principal Investigator:||Laura J. Esserman, MD, MBA||University of California, San Francisco|