Ignite Creation Date:
2025-12-24 @ 6:54 PM
Ignite Modification Date:
2026-01-01 @ 11:32 AM
Study NCT ID:
NCT02620657
Status:
COMPLETED
Last Update Posted:
2019-08-02
First Post:
2015-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate EGFR Mutation Status and Impact Factors in North China
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2809}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2017-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-01', 'studyFirstSubmitDate': '2015-12-01', 'studyFirstSubmitQcDate': '2015-12-01', 'lastUpdatePostDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To investigate the proportion of advanced NSCLC patients who performed EGFR mutation test', 'timeFrame': '2014.01.01-2014.12.31'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Approximately 3000 advanced NSCLC patients, who fulfil the inclusion/exclusion criteria, will be recruited by 30 sites in North China.', 'detailedDescription': 'Approximately 3000 advanced NSCLC patients will be recruited , and the medical information of recruited patients must be recorded in the hospital electronic system from Jan 1st 2014 to Dec 31st 2014 .The study will focus on the EGFR testing rate in adenocarcinoma patients，so the collecting data for non-adenocarcinoma patients will be controlled in less than 10% for each site.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '3000 advanced NSCLC patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological or cytological confirmed NSCLC;\n* Patients were diagnosed with advanced NSCLC from Jan 1st 2014 to Dec 31st 2014;\n* Researchers should collect the records of consecutive NSCLC patients in each site.\n\nExclusion Criteria:\n\n* Any patients without NSCLC diagnosis;\n* Any patients which were diagnosed with advanced NSCLC before Jan 1st 2014 or after Dec 31st 2014.'}, 'identificationModule': {'nctId': 'NCT02620657', 'briefTitle': 'Evaluate EGFR Mutation Status and Impact Factors in North China', 'organization': {'class': 'OTHER', 'fullName': 'Guangdong Association of Clinical Trials'}, 'officialTitle': 'A Retrospective Study on Real-world EGFR Mutation Testing Practice Status and Impact Factors in Patients With Advanced NSCLC in North China', 'orgStudyIdInfo': {'id': '11224'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non interventional study', 'description': 'The patients with advanced NSCLC who have the medical records from Jan 1st 2014 to Dec 31st 2014 will be recruited .', 'interventionNames': ['Other: Non interventional study']}], 'interventions': [{'name': 'Non interventional study', 'type': 'OTHER', 'description': 'Non interventional study', 'armGroupLabels': ['Non interventional study']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'CHENG NA Ying, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jilin Provincial Tumor Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ying cheng', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of Jilin Cancer Hospital', 'investigatorFullName': 'ying cheng', 'investigatorAffiliation': 'Guangdong Association of Clinical Trials'}}}}