Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-01-05 @ 7:27 PM
Study NCT ID:
NCT05805267
Status:
COMPLETED
Last Update Posted:
2023-04-07
First Post:
2023-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Correlation Between the Results of Specific Gene Testing and the Efficacy of Targeted Therapy in Patients With NSCLC
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': 'tissue sample and plasma DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-27', 'studyFirstSubmitDate': '2023-03-27', 'studyFirstSubmitQcDate': '2023-03-27', 'lastUpdatePostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS', 'timeFrame': '2 year', 'description': 'Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)'}], 'secondaryOutcomes': [{'measure': 'ORR', 'timeFrame': '2 years', 'description': 'Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Evaluated the correlation between the qualitative test results of Xiamen Aide the gene test specified by the test reagent and the efficacy of relevant targeted drugs in patients with non-small cell lung cancery, and the research data is used to support the registration and marketing of the assessment reagent'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with non-small cell lung cancer who have previously received or are taking gefitinib (first-line therapy) or osimertinib (post-TKI resistance) or crizotinib monotherapy', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1)≥18;\n* 2\\) advanced non-small cell lung cancer confirmed by histopathology;\n* 3\\) Patients with NSCLC who have previously or are taking gefitinib (first-line therapy) or osimertinib (post-TKI resistance) or crizotinib monotherapy, and the response to treatment can be assessed;\n* 4\\) Have sufficient FFPE tissue samples within 5 years: 5 large specimens/case; There were 10 puncture specimens/case\n\nExclusion Criteria:\n\n* 1\\) Combination therapy with chemotherapy/radiotherapy/other targeted drugs/immunotherapy drugs;\n* 2)Maintenance therapy if the disease does not progress after treatment with other antitumor methods'}, 'identificationModule': {'nctId': 'NCT05805267', 'briefTitle': 'To Evaluate the Correlation Between the Results of Specific Gene Testing and the Efficacy of Targeted Therapy in Patients With NSCLC', 'organization': {'class': 'OTHER', 'fullName': 'Hunan Province Tumor Hospital'}, 'officialTitle': 'To Evaluate the Correlation Between the Results of Specific Gene Testing and the Efficacy of Targeted Therapy in Patients With Non-small Cell Lung Cancer (NSCLC)', 'orgStudyIdInfo': {'id': 'CONFIDENCE II'}}, 'contactsLocationsModule': {'locations': [{'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Hunan Cancer hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hunan Province Tumor Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Head of Medical Oncology, Principal Investigator, Clinical Professor', 'investigatorFullName': 'Yongchang Zhang', 'investigatorAffiliation': 'Hunan Province Tumor Hospital'}}}}