Feasibility Study of Evaluating Breast Cancer Patients With Ductal Lavage
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.
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The primary purpose of this research is to analyze the cells present in the fluid obtained via ductal lavage from the nipple of a woman with a known diagnosis of breast cancer. A portion of the lavage fluid may be used in future breast cancer biomarkers. Remaining lavage fluid will be used to analyze its biochemical composition, for investigational purposes only.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
18 years of age
biopsy-proven unilateral invasive breast cancer of any histology or ductal carcinoma in situ
patient desires or requires treatment with mastectomy
any patient who has undergone prior excisional biopsy of their primary breast tumor must have had margins positive for disease, or must have either mammographic or ultrasonographic evidence of probable residual disease in the breast.
patients receiving induction chemotherapy remain eligible for participation in the study regardless of tumor response; those with a clinical complete response remain eligible.
voluntarily signed informed consent. -
lobular carcinoma in situ as the only cancerous histology
prior margin-negative excisional biopsy of primary breast tumor, with no evidence of residual disease
patient being treated with breast conservation therapy inability to understand the nature of the procedure pregnancy and/or active lactation