Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT01181518
Status:
UNKNOWN
Last Update Posted:
2013-06-03
First Post:
2010-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tamoxifen Pharmacogenetics in Asian Breast Cancer Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples for genotyping and pharmacokinetic analysis'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-05-31', 'studyFirstSubmitDate': '2010-08-12', 'studyFirstSubmitQcDate': '2010-08-12', 'lastUpdatePostDateStruct': {'date': '2013-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association between genetic polymorphisms of CYP2D6, CYP2C19, and CYP3A5 and disease free survival among tamoxifen treated breast cancer patients', 'timeFrame': 'five years', 'description': 'Association between genetic polymorphisms of CYP2D6, CYP2C19, and CYP3A5 and disease free survival among tamoxifen treated breast cancer patients'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tamoxifen', 'Pharmacogenomics', 'Breast cancer'], 'conditions': ['Poisoning by, Adverse Effect of and Underdosing of Tamoxifen']}, 'descriptionModule': {'briefSummary': 'The clinical outcome of tamoxifen treatment in breast cancer patients may be influenced by the activity of cytochrome P450 enzymes involving in tamoxifen biotransformation.', 'detailedDescription': 'The investigators investigated the prognostic and/or predictive value of genetic polymorphisms of enzymes involved in tamoxifen metabolism for the treatment outcome among Asian breast cancer patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Breast cancer patients who underwent surgery at Busan Paik Hospital, Inje University', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* incident breast cancer patients who underwent surgery\n\nExclusion Criteria:\n\n* previous cancer history before breast cancer diagnosis'}, 'identificationModule': {'nctId': 'NCT01181518', 'acronym': 'Tamoxifen', 'briefTitle': 'Tamoxifen Pharmacogenetics in Asian Breast Cancer Women', 'organization': {'class': 'OTHER', 'fullName': 'Inje University'}, 'officialTitle': 'Observational Study: Biomarker Research for Tamoxifen Pharmacogenetics Among Asian Breast Cancer Patients', 'orgStudyIdInfo': {'id': '09-140'}}, 'contactsLocationsModule': {'locations': [{'zip': '614-735', 'city': 'Busan', 'state': 'Busan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ji-Yeob Choi, Ph.D.', 'role': 'CONTACT', 'email': 'jychoi@inje.ac.kr', 'phone': '82-51-890-8663'}, {'name': 'Jae-Gook Shin, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Inje University', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}], 'centralContacts': [{'name': 'Ji-Yeob Choi, Ph.D.', 'role': 'CONTACT', 'email': 'jychoi@inje.ac.kr', 'phone': '82-51-890-8663'}], 'overallOfficials': [{'name': 'JaeGook Shin, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inje University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inje University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jae-Gook Shin', 'investigatorAffiliation': 'Inje University'}}}}