Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-29 @ 8:35 PM
Study NCT ID:
NCT01207635
Status:
COMPLETED
Last Update Posted:
2012-07-30
First Post:
2010-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Antiproliferative Effects of Arimidex in Ductal Lavage Fluid in Patients With Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'Blood drawn; and, fluids collected from ductal lavage.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-27', 'studyFirstSubmitDate': '2010-09-21', 'studyFirstSubmitQcDate': '2010-09-22', 'lastUpdatePostDateStruct': {'date': '2012-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients with Antiproliferative Effects of Arimidex', 'timeFrame': 'Study duration 4 years', 'description': 'Biomarker modulation study on effects of Armimidex in ductal lavage fluid from evaluable epithelial cells specimen.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cancer', 'Arimidex'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'UT MD Anderson Cancer Center website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to evaluate antiproliferative effects of Arimidex in ductal lavage fluids of Breast Cancer patients.\n\nBreast cancer is the leading cause of cancer incidence and the second leading cause of cancer mortality in women. Breast duct fluid provide biomarkers to aid in risk assessment of developing breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Breast cancer patients receiving standard Arimidex treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient must have a history of breast cancer.\n* Patient must be scheduled to receive standard treatment with Arimidex for adjuvant hormonal management.\n* Patient must be willing to undergo a duct lavage.\n* Patient must sign an Informed Consent.\n\nExclusion Criteria:\n\n* None.'}, 'identificationModule': {'nctId': 'NCT01207635', 'briefTitle': 'Evaluation of Antiproliferative Effects of Arimidex in Ductal Lavage Fluid in Patients With Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Evaluation of Antiproliferative Effects of Arimidex in Ductal Lavage Fluid in Patients With Breast Cancer', 'orgStudyIdInfo': {'id': 'LAB02-0400'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breast Cancer Patients', 'interventionNames': ['Procedure: Ductal Lavage Fluid Collection']}], 'interventions': [{'name': 'Ductal Lavage Fluid Collection', 'type': 'PROCEDURE', 'description': 'Procedure of inserting a small catheter into the ductal openings in the nipple and washing out cells from inside the duct.', 'armGroupLabels': ['Breast Cancer Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'UT MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Banu Arun, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'UT MD Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}