Study of Ductal Lavage in Women at High Risk for Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00429988|
Recruitment Status : Completed
First Posted : February 1, 2007
Last Update Posted : September 26, 2012
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.
|Condition or disease||Intervention/treatment|
|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|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||Ductal Lavage to Monitor and Treat High Risk Women|
|Study Start Date :||August 2002|
|Actual Primary Completion Date :||June 2004|
|Actual Study Completion Date :||June 2004|
- Average number of atypical cells per ductal lavage sample
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|