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Nipple Aspiration, Ductal Lavage, and Duct Endoscopy For Diagnostic Assessment in Women Undergoing Surgery for Breast Cancer Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Nipple Aspiration, Ductal Lavage, and Duct Endoscopy For Diagnostic Assessment in Women Undergoing Surgery for Breast Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Nipple Aspiration, Ductal Lavage, and Duct Endoscopy For Diagnostic Assessment in Women Undergoing Surgery for Breast Cancer Clinical research trials and Nipple Aspiration, Ductal Lavage, and Duct Endoscopy For Diagnostic Assessment in Women Undergoing Surgery for Breast Cancer healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Nipple Aspiration, Ductal Lavage, and Duct Endoscopy For Diagnostic Assessment in Women Undergoing Surgery for Breast Cancer. Nipple Aspiration, Ductal Lavage, and Duct Endoscopy For Diagnostic Assessment in Women Undergoing Surgery for Breast Cancer Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Nipple Aspiration, Ductal Lavage, and Duct Endoscopy For Diagnostic Assessment in Women Undergoing Surgery for Breast Cancer clinical trial. Subjects frequently obtain the most expert healthcare possible for their Nipple Aspiration, Ductal Lavage, and Duct Endoscopy For Diagnostic Assessment in Women Undergoing Surgery for Breast Cancer condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "N" Clinical Trials Conditions > Nipple Aspiration, Ductal Lavage, and Duct Endoscopy For Diagnostic Assessment in Women Undergoing Surgery for Breast Cancer  Nipple Aspiration, Ductal Lavage, and Duct Endoscopy For Diagnostic Assessment in Women Undergoing Surgery for Breast Cancer
Nipple Aspiration, Ductal Lavage, and Duct Endoscopy For Diagnostic Assessment in Women Undergoing Surgery for Breast Cancer
For Condition: stage 1 breast cancer,stage 3B breast cancer,stage 3A breast cancer,stage 2 breast cancer,stage 3C breast cancer
Status: Recruiting
Sponsor(s): Royal Marsden NHS Trust ,
Synopsis: RATIONALE: Diagnostic procedures, such as nippleaspiration, ductal lavage, and breast duct endoscopy, may help doctors detect breast cancer cells early and plan more effective treatment. PURPOSE: Phase II trial to study the effectiveness of nipple aspiration, ductal lavage, and duct endoscopy in detecting cancer cells in women who are undergoing surgery for breast cancer.
Details: 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 sensitivity and specificity of nipple aspiration, ductal lavage, and duct endoscopy in detecting established breast cancer in these patients. Secondary - Compare the intraduct environment of cancer-involved ducts in the affected breast vs the ductal systems in the contralateral breast of these patients. - Perform immunohistochemical analysis (including estrogen receptor, progesterone receptor, HER2-neu receptor, epidermal growth factor receptor, p53, and proliferation marker expression) for markers potentially associated with breast cancer in these patients. - Determine potential molecular markers of malignancy by gene methylation, gene expression, and proteomics in these patients. - Compare the biochemistry and protein analysis of the intraductal fluid vs serum analysis in these patients. OUTLINE: Patients undergo nipple aspiration, ductal lavage, and duct endoscopy under general anesthesia immediately before breast surgery. Fluid and tissue obtained are examined for tumor markers by immunohistochemistry. Candidate genes are analyzed by gene methylation, gene expression arrays, and proteomic profiling. Patients are followed at 24 hours and at 1 week. PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Diagnostic
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GeraldGui, Study Chair, Royal Marsden NHS Trust
Royal Marsden NHS Trust - London *Recruiting*
London, England, SW3 6JJ
United Kingdom
Recruiting Gerald Gui 44-20-7808-2783
Additional Information:
Study ID Numbers: CDR0000361760; RMNHS-2283,EU-20353
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00083018
Other Stage 1 Breast Cancer Studies:
1. Combination Chemotherapy in Treating Patients With High-Risk Breast Cancer
2. Combination Chemotherapy Followed by Radiation Therapy With or Without Surgery in Treating Women With Locally Advanced or Inflammatory Breast Cancer
3. Gene Therapy Plus Chemotherapy in Treating Patients With Breast Cancer
4. Combination Chemotherapy After Surgery in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer
5. Two Dose Levels of Capecitabine With Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer Who Have Not Responded to Previous Anthracycline-Based Chemotherapy
Related Studies:
Other stage 1 breast cancer Clinical Trials
Other England Clinical Trials
Other London Clinical Trials
Nipple Aspiration, Ductal Lavage, and Duct Endoscopy For Diagnostic Assessment in Women Undergoing Surgery for Breast Cancer
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