Nipple Aspiration, Ductal Lavage, and Duct Endoscopy For Diagnostic Assessment in Women Undergoing Surgery for Breast Cancer
NCT ID: NCT00083018
Last Updated: 2013-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2003-09-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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DIAGNOSTIC
Interventions
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cytogenetic analysis
proteomic profiling
cytology specimen collection procedure
immunohistochemistry staining method
laboratory biomarker analysis
breast duct lavage
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Royal Marsden NHS Foundation Trust
OTHER
Principal Investigators
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Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng)
Role: STUDY_CHAIR
Royal Marsden NHS Foundation Trust
Locations
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Royal Marsden - London
London, England, United Kingdom
Countries
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Facility Contacts
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Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng)
Role: primary
Other Identifiers
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RMNHS-2283
Identifier Type: -
Identifier Source: secondary_id
EU-20353
Identifier Type: -
Identifier Source: secondary_id
CDR0000361760
Identifier Type: -
Identifier Source: org_study_id