Feasibility Study of Evaluating Breast Cancer Patients With Ductal Lavage

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

88 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-01-31

Study Completion Date

2008-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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Ductal lavage

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. 18 years of age
2. biopsy-proven unilateral invasive breast cancer of any histology or ductal carcinoma in situ
3. patient desires or requires treatment with mastectomy
4. 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.
5. patients receiving induction chemotherapy remain eligible for participation in the study regardless of tumor response; those with a clinical complete response remain eligible.
6. voluntarily signed informed consent. -

Exclusion Criteria

1. male gender
2. lobular carcinoma in situ as the only cancerous histology
3. prior margin-negative excisional biopsy of primary breast tumor, with no evidence of residual disease
4. patient being treated with breast conservation therapy inability to understand the nature of the procedure pregnancy and/or active lactation

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Lisa Newman, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

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University of Michigan Cancer Center

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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UMCC 2-48

Identifier Type: -

Identifier Source: org_study_id