Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2025-12-27 @ 9:43 PM
Study NCT ID:
NCT04405661
Status:
UNKNOWN
Last Update Posted:
2020-05-28
First Post:
2020-05-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Specific Gene Mutationand Local Immune Microenvironment and Immunotherapy Efficacy in NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'FFPE tissue and whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2022-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-27', 'studyFirstSubmitDate': '2020-05-22', 'studyFirstSubmitQcDate': '2020-05-27', 'lastUpdatePostDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between specific gene mutation and immune microenvironment', 'timeFrame': 'up to 1year', 'description': 'Correlation between specific gene mutation and immune microenvironment'}, {'measure': 'Correlation between specific gene mutations and ORR and PFS in immunotherapy patients with lung cancerof lung cancer patients with immunotherapy', 'timeFrame': 'up to 1year', 'description': 'Correlation between specific gene mutations and ORR and PFS in immunotherapy patients with lung cancer'}, {'measure': 'Correlation between immune microenvironment and ORR and PFS in immunotherapy lung cancer patients', 'timeFrame': 'up to 1year', 'description': 'Correlation between immune microenvironment and ORR and PFS in immunotherapy lung cancer patients'}], 'secondaryOutcomes': [{'measure': 'Correlation of OS with specific gene mutation in immunotherapy of lung cancer', 'timeFrame': 'up to 1year', 'description': 'Correlation of OS with specific gene mutation in immunotherapy of lung cancer'}, {'measure': 'Correlation between immune microenvironment and OS in immunotherapy lung cancer patients', 'timeFrame': 'up to 1year', 'description': 'Correlation between immune microenvironment and OS in immunotherapy lung cancer patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PD-L1', 'NSCLC', 'Biomarker', 'mIHC', 'immune microenvironment', 'mutation', 'sequencing'], 'conditions': ['NSCLC']}, 'descriptionModule': {'briefSummary': 'Immunotherapy for PD-L1 positive patients is still ineffective in some patients，which may be related to the complex immune microenvironment.In view of this bottleneck, further refinement of immunotyping and in-depth study of drug resistance mechanism are the most important tasks. In this observational study, we evaluated the difference of gene mutation and immune microenvironment and therapeutic effect in primary NSCLC.', 'detailedDescription': 'There are still some patients with PD-L1 positive who are ineffective in immunotherapy, which may be related to the complex immune microenvironment. In view of this bottleneck, further refinement of immunotyping and in-depth study of drug resistance mechanism are the most important tasks.\n\nRecently, studies have shown that the core elements of tumor microenvironment that have a significant impact on immunotherapy are:1. Infiltration abundance of specific killer T cells; 2. PD-L1 expression dependent on IFN - γ pathway, down-regulation of various active molecules and up-regulation of inhibitory molecules; 3. Activation and clearance of various inhibitory T cells.\n\nAlthough the classification has achieved further refinement of immune cells and molecular level, there are still some problems to be solved urgently: first, the classification of TIL cells needs further refinement, and different types of TIL infiltration have different guiding significance for prognosis; second, the subjective second-order semi quantitative scoring is often used for til count scoring, with low repeatability and different centers It is not easy for different pathologists to reach an agreement on the results of reading and interpretation. Thirdly, conventional methods are difficult to meet the requirements of tumor microenvironment analysis. In conclusion, it is urgent to develop a multi molecular marker landscape analysis system for tumor microenvironment, and establish a standardized detection process for each molecule to meet the needs of clinical positioning, quantitative and qualitative analysis for key molecular markers of immune microenvironment.\n\nIn this observational study, we evaluated the difference of gene mutation and immune microenvironment and therapeutic effect in primary NSCLC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Chinese', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non small cell lung cancer was diagnosed by cytology or histopathology;\n* Patients to be treated with PD-1 / PD-L1 inhibitors;\n* Who signed the informed consent for participating in the research plan\n\nExclusion Criteria:\n\n* History of other malignancies\n* Cancer meningitis in subjects\n* Incomplete clinical follow-up data\n* Failure to sign informed consent to participate in the research program'}, 'identificationModule': {'nctId': 'NCT04405661', 'briefTitle': 'Correlation Between Specific Gene Mutationand Local Immune Microenvironment and Immunotherapy Efficacy in NSCLC', 'organization': {'class': 'OTHER', 'fullName': 'Guangzhou Institute of Respiratory Disease'}, 'officialTitle': 'Correlation Between Specific Gene Mutationand Local Immune Microenvironment and Immunotherapy Efficacy in NSCLC', 'orgStudyIdInfo': {'id': 'NSCLC-202005'}}, 'contactsLocationsModule': {'locations': [{'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chengzhi Zhou, MD', 'role': 'CONTACT', 'email': 'doctorzcz@163.com', 'phone': '+8613560351186896'}, {'name': 'Chengzhi Zhou, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'chengzhi zhou, PHD', 'role': 'CONTACT', 'email': 'doctorzcz@163.com', 'phone': '+8613560351186'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangzhou Institute of Respiratory Disease', 'class': 'OTHER'}, 'collaborators': [{'name': 'GeneCast Biotechnology Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PHD,Chief Physician', 'investigatorFullName': 'Zhou Chengzhi', 'investigatorAffiliation': 'Guangzhou Institute of Respiratory Disease'}}}}