Spots Global Cancer Trial Database for Study of Ductal Lavage in Women at High Risk for Breast Cancer

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Contact Details

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