Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2026-01-01 @ 6:52 PM
Study NCT ID:
NCT01169792
Status:
COMPLETED
Last Update Posted:
2010-07-26
First Post:
2010-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Cytochrome P450 Polymorphisms (CYP2D6, CYP3A4/5 and CYP2C19) in Breast Cancer Patients
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': 'D013629', 'term': 'Tamoxifen'}], 'ancestors': [{'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples with DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'lastUpdateSubmitDate': '2010-07-23', 'studyFirstSubmitDate': '2010-07-23', 'studyFirstSubmitQcDate': '2010-07-23', 'lastUpdatePostDateStruct': {'date': '2010-07-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The frequency of the genetic polymorphisms of CYP2D6 in breast cancer patients'}, {'measure': 'The frequency of the genetic polymorphisms of CYP3A4/5 in breast cancer patients'}, {'measure': 'The frequency of the genetic polymorphisms of CYP2C19 in breast cancer patients'}], 'secondaryOutcomes': [{'measure': 'The association between the genetic polymorphisms of CYP2D6 and outcomes in breast cancer patients with tamoxifen therapy'}, {'measure': 'The association between the genetic polymorphisms of CYP3A4/5 and outcomes in breast cancer patients with tamoxifen therapy'}, {'measure': 'The association between the genetic polymorphisms of CYP2C19 and outcomes in breast cancer patients with tamoxifen therapy'}]}, 'conditionsModule': {'keywords': ['Tamoxifen', 'Cytochrome P-450 CYP2D6', 'Polymorphism', 'Single nucleotide', 'Antineoplastic Agents, Hormonal'], 'conditions': ['Breast Neoplasms', 'Survival Analysis', 'Antineoplastic Agents', 'Therapeutic Uses']}, 'descriptionModule': {'briefSummary': 'The genetic polymorphisms of the cytochrome P450 may influence on the metabolism of tamoxifen.\n\nThe investigators want to\n\n* evaluate the frequency or incidence of the genetic polymorphisms of cytochrome P450 subfamilies(CYP2D6, CYP3A4/5 and CYP2C19) in breast cancer patients, and\n* analyze the association between the genetic polymorphisms of cytochrome P450 subfamilies and clinical outcomes in breast cancer patients treated by adjuvant tamoxifen therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Breast cancer survivors who underwent surgery at Severance hospital, Yonsei University Health System.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥ 18 years\n* Breast cancer patients who underwent surgery\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01169792', 'briefTitle': 'Study of Cytochrome P450 Polymorphisms (CYP2D6, CYP3A4/5 and CYP2C19) in Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Association Between Genetic Polymorphisms of CYP2D6 and Outcomes in Breast Cancer Patients With Tamoxifen Treatment', 'orgStudyIdInfo': {'id': '4-2009-0483'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breast cancer patients', 'description': 'Breast cancer patients who underwent surgery with or without chemotherapy, endocrine therapy and/or radiation therapy. The patients are categorized according to the genetic polymorphisms or the activity score of the cytochrome P450 metabolism.', 'interventionNames': ['Drug: tamoxifen']}], 'interventions': [{'name': 'tamoxifen', 'type': 'DRUG', 'armGroupLabels': ['Breast cancer patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': ', 614-735', 'city': 'Jin-Gu', 'state': 'Busan', 'country': 'South Korea', 'facility': 'Department of Pharmacology and Pharmacogenomics Research Center, Inje University College of Medicine'}, {'zip': '120-752', 'city': 'Saedaemoon-gu', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Surgery, Yonsei University College of Medicine'}], 'overallOfficials': [{'name': 'Byeong-Woo Park, M.D.,ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Surgery and Brain Korea 21 Project for Medical Science, Yonsei University College of Medicine'}, {'name': 'Jae-Gook Shin, M.D.,ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Pharmacology and Pharmacogenomics Research Center, Inje University College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Inje University', 'class': 'OTHER'}]}}}