Status:
UNKNOWN
Nipple Aspiration, Ductal Lavage, and Duct Endoscopy For Diagnostic Assessment in Women Undergoing Surgery for Breast Cancer
Lead Sponsor:
Royal Marsden NHS Foundation Trust
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Diagnostic procedures, such as nipple aspiration, ductal lavage, and breast duct endoscopy, may help doctors detect and assess breast cancer cells early and plan more effective treatment. ...
Detailed Description
OBJECTIVES: Primary * Correlate the cell yield and morphology findings from ductal lavage with duct endoscopy findings and surgical pathology findings in women with breast cancer. * Determine the se...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of breast cancer
- No metastatic disease
- No inflammatory breast cancer
- Hormone receptor status:
- Not specified
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Sex
- Female
- Menopausal status
- Not specified
- Performance status
- Not specified
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- Not specified
- Renal
- Not specified
- Other
- No active infection or inflammation in the breast under study
- No known allergy to eutectic mixture of local anesthetics (EMLA®) cream or lidocaine
- No severe illness
- Not unconscious
- No mental illness or handicap
- No nursing within the past 12 months
- Not pregnant
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- Not specified
- Endocrine therapy
- Not specified
- Radiotherapy
- Not specified
- Surgery
- No prior breast implantation on side of proposed lavage
- No prior subareolar (e.g., papilloma resections, biopsies, or fine needle aspirations) or other surgery that may disrupt the ductal systems within 2 cm of the nipple
- Biopsies and fine-needle aspirations \> 2 cm from the nipple are allowed
Exclusion
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00083018
Start Date
September 1 2003
Last Update
August 26 2013
Active Locations (1)
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1
Royal Marsden - London
London, England, United Kingdom, SW3 6JJ