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

Sponsored by:	Royal Marsden - London
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00081003

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:	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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Endoscopy

U.S. FDA Resources

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

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

Locations

United Kingdom, England
Royal Marsden - London	Recruiting
London, England, United Kingdom, SW3 6JJ
Contact: Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng) 44-20-7808-2783 gerald.gui@rmh.nhs.uk

Sponsors and Collaborators

Royal Marsden - London

Investigators

Study Chair:

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

Royal Marsden - London

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000358797, RMNHS-2278, EU-20352
Study First Received:	April 7, 2004
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00081003 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

breast cancer

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on September 10, 2009