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Nipple Aspiration, Ductal Lavage, and Duct Endoscopy in Screening Women at Moderate-to-High Risk of Developing Breast Cancer

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ClinicalTrials.gov Identifier: NCT00081003
Recruitment Status : Completed
First Posted : April 8, 2004
Last Update Posted : July 23, 2014
Information provided by:

Study Description
Brief Summary:

RATIONALE: Screening tests, such as nipple aspiration, ductal lavage, and breast duct endoscopy, may help doctors detect cancer cells early and plan more effective treatment for breast cancer.

PURPOSE: This clinical trial is studying how well nipple aspiration, ductal lavage, and breast duct endoscopy work in detecting cancer cells in healthy women who are at moderate-to-high risk of developing breast cancer.

Condition or disease Intervention/treatment
Breast Cancer Genetic: gene expression analysis Genetic: protein expression analysis Other: cytology specimen collection procedure Other: laboratory biomarker analysis Other: physiologic testing Procedure: breast duct lavage Procedure: endoscopic biopsy Procedure: study of high risk factors

Detailed Description:



  • Determine the incidence of mild or severe cellular atypia in nipple aspirate fluid of healthy women at moderate to high risk of developing breast cancer, defined by family history or prior atypical biopsy.


  • Correlate cellular atypia with breast cancer, biochemical tumor markers, growth factors, and genetic and protein markers in these participants.
  • Determine cancer risk and incidence utilizing these methods of screening in these participants.
  • Observe the natural history of atypia in these participants over a total of 10 years.
  • Determine whether these techniques may serve as supplementary tools in future screening of these participants.

OUTLINE: Participants under 50 years of age undergo nipple aspiration every twelve months for 3 years. Participants over 50 years of age undergo nipple aspiration every 18 months for 4.5 years.

Participants with significant cellular atypia in nipple aspirate fluid undergo ductal lavage and endoscopy.

Participants are followed annually for a total of 10 years.

PROJECTED ACCRUAL: A total of 1,000 participants will be accrued for this study within approximately 4 years.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Primary Purpose: Screening
Official Title: The Intraduct Environment: A Novel Approach to Risk Assessment of Women With a Family History of Breast Cancer
Study Start Date : November 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

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:   Yes


  • Significant family history or prior atypical biopsy indicative of a moderate or high risk of developing breast cancer
  • No concurrent inflammatory breast cancer
  • Hormone receptor status:

    • Not specified



  • 18 to 64


  • Female

Menopausal Status

  • Premenopausal or postmenopausal

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • No prior allergy to EMLA cream or lidocaine
  • No severe illness that would preclude study participation
  • No mental illness or handicap that would preclude study compliance
  • No concurrent active infection or inflammation in the breast being studied
  • Not unconscious
  • Not pregnant
  • No nursing within the past 12 months


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • No prior subareolar surgery (e.g., microdochectomy or major duct excision) that may disrupt the ductal systems within 2 cm of the nipple
  • No prior breast implantation on proposed lavage side
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00081003

United Kingdom
Royal Marsden - London
London, England, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Study Chair: Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng) Royal Marsden NHS Foundation Trust
More Information

ClinicalTrials.gov Identifier: NCT00081003     History of Changes
Other Study ID Numbers: CDR0000358797
First Posted: April 8, 2004    Key Record Dates
Last Update Posted: July 23, 2014
Last Verified: December 2005

Keywords provided by National Cancer Institute (NCI):
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases