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Sponsored by: |
Royal Marsden - London |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00083018 |
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.
PURPOSE: This phase II trial is studying how well nipple aspiration, ductal lavage, and duct endoscopy work in assessing cancer cells in women who are undergoing surgery for breast cancer.
Condition | Intervention | Phase |
Breast Cancer |
Procedure: breast duct lavage Procedure: cytogenetic analysis Procedure: cytology specimen collection procedure Procedure: laboratory biomarker analysis |
Phase II |
Genetics Home Reference related topics: | breast cancer |
MedlinePlus related topics: | Breast Cancer Cancer Endoscopy |
Study Type: | Interventional |
Study Design: | Diagnostic |
Official Title: | Evaluation Of The Role Of Nipple Aspiration, Ductal Lavage And Duct Endoscopy At The Time Of Surgery In Patients With Breast Cancer |
Estimated Enrollment: | 100 |
Study Start Date: | September 2003 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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
United Kingdom, England | |||||
Royal Marsden - London | Recruiting | ||||
London, England, United Kingdom, SW3 6JJ | |||||
Contact: Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng) 44-20-7808-2783 gerald.gui@rmh.nhs.uk |
Royal Marsden - London |
Study Chair: | Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng) | Royal Marsden - London |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000361760, RMNHS-2283, EU-20353 |
First Received: | May 14, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00083018 |
Health Authority: | Unspecified |
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