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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2005 by National Cancer Institute (NCI).
Recruitment status was Recruiting

Sponsor:

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00081003

First received: April 7, 2004

Last updated: February 6, 2009

Last verified: December 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

April 7, 2004

Last Updated Date

February 6, 2009

Start Date ^ICMJE

November 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00081003 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

The Intraduct Environment: A Novel Approach to Risk Assessment of Women With a Family History of Breast Cancer

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Study Design ^ICMJE

Primary Purpose: Screening

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

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 Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

1000

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 64 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00081003

Other Study ID Numbers ^ICMJE

CDR0000358797, RMNHS-2278, EU-20352

Has Data Monitoring Committee

Responsible Party

Study Sponsor ^ICMJE

Royal Marsden NHS Foundation Trust

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng)

Royal Marsden NHS Foundation Trust

Information Provided By

National Cancer Institute (NCI)

Verification Date

December 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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