Nipple Aspiration, Ductal Lavage, and Duct Endoscopy For Diagnostic Assessment in Women Undergoing Surgery for Breast Cancer

NCT00083018 | Unknown Phase 2

• 3 other identifiers: CDR0000361760RMNHS-2283EU-20353
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Diagnostic procedures, such as nipple aspiration, ductal lavage, and breast duct endoscopy, may help doctors detect and assess breast cancer cells early and plan more effective treatment. PURPOSE: This phase II trial is studying how well nipple aspiration, ductal lavage, and duct endoscopy work in assessing cancer cells in women who are undergoing surgery for breast cancer.

Conditions

Breast Cancer

Keywords

stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IA breast cancer; stage IB breast cancer

Outcome Measures

Primary Outcomes (3)

• Correlation of cell yields and morphology in ductal lavage with duct endoscopy appearances and findings

• Sensitivity and specificity of ductal lavage with or without ductoscopy in detecting atypical cells

• Comparison of cell yields vs final surgical pathology of the operative specimens

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+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of breast cancer * No metastatic disease * No inflammatory breast cancer * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Female Menopausal status * Not specified Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * No active infection or inflammation in the breast under study * No known allergy to eutectic mixture of local anesthetics (EMLA®) cream or lidocaine * No severe illness * Not unconscious * No mental illness or handicap * No nursing within the past 12 months * Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * No prior breast implantation on side of proposed lavage * No prior subareolar (e.g., papilloma resections, biopsies, or fine needle aspirations) or 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

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 CHAIR

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: September 1, 2003
• Last Updated: August 26, 2013

Record last verified: 2005-12

Locations

GB (1)