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

NCT00081003 | Completed

• 3 other identifiers: CDR0000358797RMNHS-2278EU-20352
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast cancer

Interventions

gene expression analysis GENETIC

protein expression analysis GENETIC

cytology specimen collection procedure OTHER

laboratory biomarker analysis OTHER

physiologic testing OTHER

breast duct lavage PROCEDURE

endoscopic biopsy PROCEDURE

study of high risk factors PROCEDURE

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

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

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Gene Expression Profiling; Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Genetic Techniques; Investigative Techniques; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

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

  Royal Marsden NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: SCREENING
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 7, 2004
• First Posted: April 8, 2004
• Study Start: November 1, 2003
• Last Updated: July 23, 2014

Record last verified: 2005-12

Locations

GB (1)