Completed

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

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What is being tested

gene expression analysis

+ protein expression analysis
+ cytology specimen collection procedure
Genetic
Other
Procedure
Who is being recruted

Breast Cancer

From 18 to 64 Years
How is the trial designed

Screening Study

Interventional
Study Start: November 2003

Summary

Principal SponsorRoyal Marsden NHS Foundation Trust
Last updated: July 23, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: November 1, 2003Actual date on which the first participant was enrolled.

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. 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.

Official TitleThe Intraduct Environment: A Novel Approach to Risk Assessment of Women With a Family History of Breast Cancer 
Principal SponsorRoyal Marsden NHS Foundation Trust
Last updated: July 23, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
1000 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Screening Study
Screening studies test new methods to find diseases or risk factors early—before any symptoms appear. This helps catch health issues sooner, when they may be easier to treat.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
From 18 to 64 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Breast Cancer
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



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Royal Marsden - LondonLondon, United KingdomSee the location

CompletedOne Study Center