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Duct Endoscopy in Assessing Cellular Atypia in the Breast Duct Fluid of Women With a Genetic Risk for Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00082979
Recruitment Status : Unknown
Verified December 2005 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : May 17, 2004
Last Update Posted : August 26, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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 or disease Intervention/treatment Phase
Breast Cancer Genetic: cytogenetic analysis Genetic: proteomic profiling Other: cytology specimen collection procedure Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: breast duct lavage Phase 2

Detailed Description:



  • Correlate cell yield and morphology findings from ductal lavage with duct endoscopy findings and any subsequent surgical pathology findings in high-risk women with BRCA1, BRCA2, or p53 gene mutations who have cellular atypia.
  • Determine the prevalence of occult breast cancer in patients with cellular atypia undergoing duct endoscopy.


  • Determine patient acceptance of duct endoscopy.
  • 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.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Primary Purpose: 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
Study Start Date : October 2003

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Comparison of cell yields and morphology from ductal lavage vs the ductal anatomy visualized at duct endoscopy
  2. Prevalence of occult pathology (malignant and benign) as assessed by duct endoscopy on intraduct sampling
  3. Sensitivity and specificity of ductal lavage to duct endoscopy in detecting atypia or malignancy
  4. Comparison of cell yields vs final surgical pathology

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Diagnosis of cellular atypia in nipple aspirate or ductal lavage fluid
  • Enrollment on RMNHS-2242 or RMNHS-2269 required
  • No inflammatory breast cancer
  • Hormone receptor status:

    • Not specified



  • 18 to 64


  • Female

Menopausal Status

  • Any status

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • No prior allergy to eutectic mixture of local anesthetics (EMLA®) cream or lidocaine
  • No severe illness that would preclude study participation
  • No mental illness or handicap that would preclude study compliance
  • No active infection or inflammation in the breast being studied
  • No nursing within the past 12 months
  • Not pregnant
  • Not unconscious


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • No prior tamoxifen


  • Not specified


  • 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

    • Biopsies and fine needle aspirations > 2 cm from the nipple are allowed
  • No prior breast implantation on proposed lavage side


  • No prior chemopreventative agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00082979

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United Kingdom
Royal Marsden - London Recruiting
London, England, United Kingdom, SW3 6JJ
Contact: Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng)    44-20-7808-2783   
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
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OverallOfficial: Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng) Royal Marsden NHS Foundation Trust
Layout table for additonal information Identifier: NCT00082979    
Other Study ID Numbers: CDR0000361751
First Posted: May 17, 2004    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: December 2005
Keywords provided by National Cancer Institute (NCI):
breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases