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

NCT ID: NCT00081003

Last Updated: 2014-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-11-30

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.

Conditions

Breast Cancer

Study Design

• Primary Study Purpose: SCREENING

Interventions

gene expression analysis

Intervention Type: GENETIC

protein expression analysis

Intervention Type: GENETIC

cytology specimen collection procedure

Intervention Type: OTHER

laboratory biomarker analysis

Intervention Type: OTHER

physiologic testing

Intervention Type: OTHER

breast duct lavage

Intervention Type: PROCEDURE

endoscopic biopsy

Intervention Type: PROCEDURE

study of high risk factors

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role: lead

Principal Investigators

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

Role: STUDY_CHAIR

Royal Marsden NHS Foundation Trust

Locations

Royal Marsden - London

London, England, United Kingdom

Countries

United Kingdom

Other Identifiers

RMNHS-2278

Identifier Type: -

Identifier Source: secondary_id

EU-20352

Identifier Type: -

Identifier Source: secondary_id

CDR0000358797

Identifier Type: -

Identifier Source: org_study_id