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Sponsored by: |
Royal Marsden - London |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00082979 |
RATIONALE: Diagnostic procedures, such as breast duct endoscopy, may improve the ability to detect breast cancer earlier and plan more effective treatment.
PURPOSE: This phase II trial is studying how well breast duct endoscopy works in assessing cellular atypia (abnormal cells) in the breast ducts of women with a genetic risk for breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Genetic: cytogenetic analysis Other: cytology specimen collection procedure Other: laboratory biomarker analysis Procedure: breast duct lavage |
Phase II |
Study Type: | Interventional |
Study Design: | Diagnostic |
Official Title: | Evaluation of the Role of Duct Endoscopy in the Assessment of Cellular Atypia Within Breast Duct Fluid in High-Risk Women Carrying BRCA1/2 or p53 Gene Mutations |
Estimated Enrollment: | 60 |
Study Start Date: | October 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients undergo nipple aspiration to identify productive ducts and collect fluid for tumor marker assessment followed by ductal lavage over 15 minutes. Patients undergo duct endoscopy over approximately 30 minutes under local anesthesia. If no abnormality is found, duct endoscopy is repeated in 6 months. If the repeat duct endoscopy is normal, patients continue to undergo nipple aspiration or ductal lavage as specified in protocols RMNHS-2242 and RMNHS-2269. If an abnormality is found during either the initial or repeat duct endoscopy, patients may undergo further assessment comprising imaging or biopsy and/or appropriate surgical intervention.
Fluid is analyzed for tumor markers by immunohistochemistry. Candidate genes are analyzed by gene methylation studies, gene expression arrays, and proteomic analysis.
Patients are followed for at least 5 years.
PROJECTED ACCRUAL: A total of 45-60 patients will be accrued for this study within 2 years.
Ages Eligible for Study: | 18 Years to 64 Years |
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 surgery (e.g., papilloma resections, biopsies, or fine needle aspirations) or any other surgery that may disrupt the ductal systems within 2 cm of the nipple
Other
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 |
Investigator: | Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng) | Royal Marsden - London |
Study ID Numbers: | CDR0000361751, RMNHS-2282, EU-20351 |
Study First Received: | May 14, 2004 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00082979 History of Changes |
Health Authority: | Unspecified |
breast cancer |
Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |