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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00081003
First received: April 7, 2004
Last updated: July 22, 2014
Last verified: December 2005
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Primary Purpose: Screening
Official Title: The Intraduct Environment: A Novel Approach to Risk Assessment of Women With a Family History of Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 1000
Study Start Date: November 2003
Detailed Description:

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 to 64

Sex

  • Female

Menopausal Status

  • Premenopausal or postmenopausal

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00081003

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00081003     History of Changes
Other Study ID Numbers: CDR0000358797, RMNHS-2278, EU-20352
Study First Received: April 7, 2004
Last Updated: July 22, 2014
Health Authority: Unspecified

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

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

ClinicalTrials.gov processed this record on September 22, 2014