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Evaluation of the Role of Duct Endoscopy in the Assessment of Cellular Atypia Within Breast Duct Fluid in High-Risk Women Carrying BRCA1/2 or p53 Gene Mutations

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What is being tested

Data Collection

Who is being recruted

Breast Diseases+2

+ Breast Neoplasms

+ Neoplasms

From 18 to 64 Years
See all eligibility criteria
How is the trial designed

Diagnostic Study

Phase 2
Interventional
Study Start: October 2003
See protocol details

Summary

Principal SponsorRoyal Marsden NHS Foundation Trust
Last updated: January 14, 2026
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Study start date: October 1, 2003

Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Correlate cell yield and morphology findings from ductal lavage with duct endoscopy findings and any subsequent surgical pathology findings in high-risk women with BRCA1, BRCA2, or p53 gene mutations who have cellular atypia. * Determine the prevalence of occult breast cancer in patients with cellular atypia undergoing duct endoscopy. Secondary * Determine patient acceptance of duct endoscopy. * Perform immunohistochemical analysis (including estrogen receptor, progesterone receptor, HER2-neu receptor, epidermal growth factor receptor, p53, and proliferation marker expression) for markers potentially associated with breast cancer in these patients. * Determine potential molecular markers of malignancy by gene methylation, gene expression, and proteomics in these patients. OUTLINE: Patients undergo nipple aspiration to identify productive ducts and collect fluid for tumor marker assessment followed by ductal lavage over 15 minutes. Patients undergo duct endoscopy over approximately 30 minutes under local anesthesia. If no abnormality is found, duct endoscopy is repeated in 6 months. If the repeat duct endoscopy is normal, patients continue to undergo nipple aspiration or ductal lavage as specified in protocols RMNHS-2242 and RMNHS-2269. If an abnormality is found during either the initial or repeat duct endoscopy, patients may undergo further assessment comprising imaging or biopsy and/or appropriate surgical intervention. Fluid is analyzed for tumor markers by immunohistochemistry. Candidate genes are analyzed by gene methylation studies, gene expression arrays, and proteomic analysis. Patients are followed for at least 5 years. PROJECTED ACCRUAL: A total of 45-60 patients will be accrued for this study within 2 years.

Official TitleEvaluation of the Role of Duct Endoscopy in the Assessment of Cellular Atypia Within Breast Duct Fluid in High-Risk Women Carrying BRCA1/2 or p53 Gene Mutations 
NCT00082979
Principal SponsorRoyal Marsden NHS Foundation Trust
Last updated: January 14, 2026
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

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 64 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin Diseases

Criteria

DISEASE CHARACTERISTICS: * Diagnosis of cellular atypia in nipple aspirate or ductal lavage fluid * Enrollment on RMNHS-2242 or RMNHS-2269 required * No inflammatory breast cancer * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 to 64 Sex * Female Menopausal Status * Any status Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * No prior allergy to eutectic mixture of local anesthetics (EMLA®) cream or lidocaine * No severe illness that would preclude study participation * No mental illness or handicap that would preclude study compliance * No active infection or inflammation in the breast being studied * No nursing within the past 12 months * Not pregnant * Not unconscious PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * No prior tamoxifen Radiotherapy * Not specified Surgery * No prior subareolar surgery (e.g., papilloma resections, biopsies, or fine needle aspirations) or any other surgery that may disrupt the ductal systems within 2 cm of the nipple * Biopsies and fine needle aspirations \> 2 cm from the nipple are allowed * No prior breast implantation on proposed lavage side Other * No prior chemopreventative agents

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

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

Recruiting

Royal Marsden - London

London, United KingdomSee the location
SuspendedOne Study Center