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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00081003

Enrollment

1000

Registered

2004-04-08

Start date

2003-11-30

Completion date

Unknown

Last updated

2014-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

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.

Interventions

OTHERlaboratory biomarker analysis

OTHERphysiologic testing

PROCEDUREbreast duct lavage

GENETICgene expression analysis

GENETICprotein expression analysis

OTHERcytology specimen collection procedure

PROCEDUREendoscopic biopsy

PROCEDUREstudy of high risk factors

Study design

Primary purpose

SCREENING

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 64 Years

Healthy volunteers

Yes

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026