Status:
COMPLETED
Studying Cells Collected Through Ductal Lavage in Women Undergoing Surgery for Ductal Carcinoma In Situ or Other Breast Cancer
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
Up to 120 years
Brief Summary
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This ...
Detailed Description
OBJECTIVES: * Determine the expression pattern of the programmed cell death (PCD) regulatory genes bcl-2, bax, and bcl-xL in primary ductal carcinoma in situ (DCIS) cultures. * Determine whether down...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Agrees to undergo breast surgical procedure AND meets one of the following criteria:
- Scheduled to undergo breast biopsy based on suspicious mammographic or clinical breast examination findings
- Diagnosis of ductal carcinoma in situ (DCIS) or carcinoma in the breast to be studied (opposite breast may also be studied)
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- Female
- Pre- or post-menopausal
- Not currently pregnant or pregnant within the past 12 months
- Must not have lactated within the past 12 months
- No active infection or inflammation in the breast to be studied
- No known allergy to lidocaine, prilocaine, or marcaine (bupivacaine)
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior subareolar surgery or other breast procedure that may disrupt the ductal system within 2 cm of the nipple in the breast to be studied
- No prior breast implant that disrupts the ductal architecture in the breast to be studied
- No prior silicone injections in the breast to be studied
- No prior radiotherapy to the breast to be studied
- No chemotherapy within the past 6 months
- Concurrent prophylactic chemotherapy allowed
- No concurrent participation in another research study that may conflict with or affect the outcome of this study
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00896857
Start Date
April 1 2004
End Date
February 1 2008
Last Update
March 15 2017
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