Duct Endoscopy in Assessing Cellular Atypia in the Breast Duct Fluid of Women With a Genetic Risk for Breast Cancer

NCT00082979 | Unknown Phase 2

• 3 other identifiers: CDR0000361751RMNHS-2282EU-20351
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Diagnostic procedures, such as breast duct endoscopy, may improve the ability to detect breast cancer earlier and plan more effective treatment. PURPOSE: This phase II trial is studying how well breast duct endoscopy works in assessing cellular atypia (abnormal cells) in the breast ducts of women with a genetic risk for breast cancer.

Conditions

Breast Cancer

Keywords

breast cancer

Outcome Measures

Primary Outcomes (4)

• Comparison of cell yields and morphology from ductal lavage vs the ductal anatomy visualized at duct endoscopy

• Prevalence of occult pathology (malignant and benign) as assessed by duct endoscopy on intraduct sampling

• Sensitivity and specificity of ductal lavage to duct endoscopy in detecting atypia or malignancy

• Comparison of cell yields vs final surgical pathology

Interventions

cytogenetic analysis GENETIC

proteomic profiling GENETIC

cytology specimen collection procedure OTHER

immunohistochemistry staining method OTHER

laboratory biomarker analysis OTHER

breast duct lavage PROCEDURE

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

Royal Marsden - London

London, England, SW3 6JJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cytogenetic Analysis; Immunohistochemistry

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Histocytochemistry; Histological Techniques; Immunologic Techniques

Study Officials

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

  Royal Marsden NHS Foundation Trust

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: DIAGNOSTIC
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 14, 2004
• First Posted: May 17, 2004
• Study Start: October 1, 2003
• Last Updated: August 26, 2013

Record last verified: 2005-12

Locations

GB (1)