Breast Cancer Clinical Trial
Official title:
Ductal Lavage to Monitor and Treat High Risk Women
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.
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.
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Observational Model: Cohort, Time Perspective: Prospective
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