Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-29 @ 11:39 AM
Study NCT ID:
NCT00081003
Status:
COMPLETED
Last Update Posted:
2014-07-23
First Post:
2004-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nipple Aspiration, Ductal Lavage, and Duct Endoscopy in Screening Women at Moderate-to-High Risk of Developing Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020869', 'term': 'Gene Expression Profiling'}, {'id': 'D000069916', 'term': 'Endoscopic Mucosal Resection'}], 'ancestors': [{'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'SCREENING'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-12', 'lastUpdateSubmitDate': '2014-07-22', 'studyFirstSubmitDate': '2004-04-07', 'studyFirstSubmitQcDate': '2004-04-07', 'lastUpdatePostDateStruct': {'date': '2014-07-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-04-08', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['breast cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: 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.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* 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.\n\nSecondary\n\n* Correlate cellular atypia with breast cancer, biochemical tumor markers, growth factors, and genetic and protein markers in these participants.\n* Determine cancer risk and incidence utilizing these methods of screening in these participants.\n* Observe the natural history of atypia in these participants over a total of 10 years.\n* Determine whether these techniques may serve as supplementary tools in future screening of these participants.\n\nOUTLINE: 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.\n\nParticipants with significant cellular atypia in nipple aspirate fluid undergo ductal lavage and endoscopy.\n\nParticipants are followed annually for a total of 10 years.\n\nPROJECTED ACCRUAL: A total of 1,000 participants will be accrued for this study within approximately 4 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Significant family history or prior atypical biopsy indicative of a moderate or high risk of developing breast cancer\n* No concurrent inflammatory breast cancer\n* Hormone receptor status:\n\n * Not specified\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 to 64\n\nSex\n\n* Female\n\nMenopausal Status\n\n* Premenopausal or postmenopausal\n\nPerformance status\n\n* Not specified\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Not specified\n\nHepatic\n\n* Not specified\n\nRenal\n\n* Not specified\n\nOther\n\n* No prior allergy to EMLA cream or lidocaine\n* No severe illness that would preclude study participation\n* No mental illness or handicap that would preclude study compliance\n* No concurrent active infection or inflammation in the breast being studied\n* Not unconscious\n* Not pregnant\n* No nursing within the past 12 months\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* Not specified\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* No prior subareolar surgery (e.g., microdochectomy or major duct excision) that may disrupt the ductal systems within 2 cm of the nipple\n* No prior breast implantation on proposed lavage side'}, 'identificationModule': {'nctId': 'NCT00081003', 'briefTitle': 'Nipple Aspiration, Ductal Lavage, and Duct Endoscopy in Screening Women at Moderate-to-High Risk of Developing Breast Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'The Intraduct Environment: A Novel Approach to Risk Assessment of Women With a Family History of Breast Cancer', 'orgStudyIdInfo': {'id': 'CDR0000358797'}, 'secondaryIdInfos': [{'id': 'RMNHS-2278'}, {'id': 'EU-20352'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'gene expression analysis', 'type': 'GENETIC'}, {'name': 'protein expression analysis', 'type': 'GENETIC'}, {'name': 'cytology specimen collection procedure', 'type': 'OTHER'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER'}, {'name': 'physiologic testing', 'type': 'OTHER'}, {'name': 'breast duct lavage', 'type': 'PROCEDURE'}, {'name': 'endoscopic biopsy', 'type': 'PROCEDURE'}, {'name': 'study of high risk factors', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW3 6JJ', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Marsden - London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng)', 'role': 'STUDY_CHAIR', 'affiliation': 'Royal Marsden NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Marsden NHS Foundation Trust', 'class': 'OTHER'}}}}