COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Nipple Aspiration, Ductal Lavage, and Duct Endoscopy For Diagnostic Assessment in Women Undergoing Surgery 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: NCT00083018
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 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 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 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.


  • 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Primary Purpose: 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
Study Start Date : September 2003

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Correlation of cell yields and morphology in ductal lavage with duct endoscopy appearances and findings
  2. Sensitivity and specificity of ductal lavage with or without ductoscopy in detecting atypical cells
  3. Comparison of cell yields vs final surgical pathology of the operative specimens

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Diagnosis of breast cancer
  • No metastatic disease
  • No inflammatory breast cancer
  • Hormone receptor status:

    • Not specified



  • 18 and over


  • Female

Menopausal status

  • Not specified

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • 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


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • 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

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): NCT00083018

Layout table for location information
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
Layout table for investigator information
Study Chair: Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng) Royal Marsden NHS Foundation Trust
Layout table for additonal information Identifier: NCT00083018    
Other Study ID Numbers: CDR0000361760
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):
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IA breast cancer
stage IB breast cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases