Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-04-15 @ 4:40 AM
Study NCT ID:
NCT02708667
Status:
UNKNOWN
Last Update Posted:
2016-03-15
First Post:
2016-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Research Of Crizotinib's Hepatic Toxicity In Non-small Cell Lung Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood, biopsy tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-09', 'studyFirstSubmitDate': '2016-03-05', 'studyFirstSubmitQcDate': '2016-03-09', 'lastUpdatePostDateStruct': {'date': '2016-03-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of patients with adverse events', 'timeFrame': 'change from the date of taking crizotinib at 9 months'}], 'secondaryOutcomes': [{'measure': 'progression free survival', 'timeFrame': 'from the date of taking crizotinib to the date of objective tumor progression or date of death from any cause,whichever came first,assessed up to 48 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['non-small cell lung cancer', 'crizotinib', 'hepatic toxicity'], 'conditions': ['Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Crizotinib, an inhibitor of anaplastic lymphoma kinase (ALK), was approved by Food and Drug Administration (FDA) for the treatment of patients with ALK-positive non-small cell lung cancer (NSCLC) and its administration has achieved considerable success. However, adverse effects inevitably occurred and the most common one was hepatic toxicity, appearing as elevating alanine aminotransferase(ALT) and aspartate aminotransferase(AST). Therefore, the investigators try to figure out the mechanism of crizotinib-inducing hepatic toxicity, and explore whether there is any biological marker to diagnose this side effect in an early stage, which may realize individualized therapy with more efficacy and less side effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who were diagnosed with stage III or IV non-small cell lung cancer (NSCLC), harbored ALK fusion gene and took crizotinib.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. patients who were histologically and cytologically confirmed NSCLC at stage III or IV\n2. harbored ALK fusion gene and took crizotinib\n3. age:18\\~75years\n4. Eastern cooperative oncology group performance status(ECOG PS): 0\\~2 points\n5. the expected lifetime is more than 12 weeks after being recruited\n\nExclusion Criteria:\n\n1. patients who also suffered from other malignant tumor\n2. uncontrolled systemic diseases,central nervous system (CNS) metastasis\n3. clinically active interstitial lung diseases\n4. severe liver dysfunction caused by hepatic cirrhosis or hepatitis （Child-Pugh class C, total index score 10-15 points）\n5. taking drugs that interact with crizotinib'}, 'identificationModule': {'nctId': 'NCT02708667', 'briefTitle': "An Observational Research Of Crizotinib's Hepatic Toxicity In Non-small Cell Lung Cancer Patients", 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': "An Observational Research on Relationship Between c-Met Gene Polymorphism, Promoter Methylation Level, Related Drug Metabolism Enzymes and Crizotinib's Hepatic Toxicity in Non-small Cell Lung Cancer Patients", 'orgStudyIdInfo': {'id': '2015-FXY-078-Internal medicine'}}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Likun Chen, doctor', 'role': 'CONTACT', 'phone': '13798019964'}], 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Likun Chen', 'role': 'CONTACT', 'email': 'chenlk@sysucc.org.cn', 'phone': '020-87342475'}], 'overallOfficials': [{'name': 'Likun Chen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor/Associate chief physician', 'investigatorFullName': 'Li-kun Chen', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}