Feasibility Study of Evaluating Breast Cancer Patients With Ductal Lavage

Stopped early

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID: NCT00156260
Run by: University of Michigan Rogel Cancer Center
People needed: 88
Starts: 2003-01-01
Expected to finish: 2008-10-01
Last updated by the study team: 2008-10-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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. -

You may not qualify if…

male gender
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

Where it is running

University of Michigan Cancer Center — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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