Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 10:28 PM
Study NCT ID:
NCT06142058
Status:
RECRUITING
Last Update Posted:
2023-11-21
First Post:
2023-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RecistTM Criteria in Evaluating the Efficacy of Targeted Therapy for NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D066066', 'term': 'Response Evaluation Criteria in Solid Tumors'}], 'ancestors': [{'id': 'D016896', 'term': 'Treatment Outcome'}, {'id': 'D011379', 'term': 'Prognosis'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Patient ctDNA samples are used for NGS detections, with each patient planning to take blood 3-4 times。'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-13', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-15', 'studyFirstSubmitDate': '2023-10-31', 'studyFirstSubmitQcDate': '2023-11-15', 'lastUpdatePostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The correlation between the efficacy evaluation results of the RecistTM criteria and the results of ctDNA testing', 'timeFrame': 'At the 1st, 3rd, 6th month after treatment, and at the time of disease progression, up to 2 years', 'description': 'The correlation between the efficacy evaluated by the RecistTM criteria and the ctDNA amounts detected by NGS'}], 'primaryOutcomes': [{'measure': 'Evaluation consistency', 'timeFrame': 'efficacy evaluation at the 1st, 3rd, 6th month after treatment, and every 3 months thereafter up to 1 year', 'description': 'The ratio of the number of patients with the same efficacy evaluated both by RecistTM and Recist criteria to the total number of the patients.'}], 'secondaryOutcomes': [{'measure': 'progression-free survival （PFS）', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months', 'description': 'The correlation between the efficacy evaluation results of the RecistTM criteria and the RECIST criteria and PFS'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tumor marker', 'NSCLC', 'RECIST', 'RecistTM', 'positive driving gene'], 'conditions': ['Evaluation', 'NSCLC', 'Targeted Therapy']}, 'descriptionModule': {'briefSummary': 'Investigators established the efficacy evaluation criteria for tumor markers (RecistTM) in the preliminary research. Among patients with advanced non-small cell lung cancer, patients with positive driving genes are more likely to exhibit abnormalities in tumor markers, which suggests that this criteria may be more suitable for evaluating the efficacy of targeted therapy in driving gene positive patients. Moreover, The judgment rules of the prelimary criteria still need further improvement. Therefore, in order to broaden the application scope of the RecistTM criteria, further improve the evaluation rules of RecistTM criteria, and multi-dimensionally confirm the reliability of RecistTM criteria on efficacy evaluation, investigators plan to conduct research on the application of RecistTM criteria in evaluating the efficacy of targeted therapy for advanced non-small cell lung cancer with positive driving genes.', 'detailedDescription': 'Investigators established the efficacy evaluation criteria for tumor markers (RecistTM) in the preliminary research. The establishment of this criteria makes the application of tumor markers in clinical efficacy evaluation more objective and solves the problem of consistency in clinical efficacy evaluation. Among patients with advanced non-small cell lung cancer, patients with positive driving genes are more likely to exhibit abnormalities in tumor markers, which suggests that this criteria may be more suitable for evaluating the efficacy of targeted therapy in driving gene positive patients. Moreover, The judgment rules of the preliminary criteria still need further improvement. . Therefore, in order to broaden the application scope of the RecistTM criteria, further improve the evaluation rules of RecistTM criteria, and multi-dimensionally confirm the reliability of RecistTM criteria on efficacy evaluation, investigators plan to conduct research on the application of RecistTM criteria in evaluating the efficacy of targeted therapy for advanced non-small cell lung cancer with positive driving genes. Investigators used statistical analysis to assess the consistency of efficacy evaluation between the RecistTM criteria and the RECIST criteria, the correlation between different efficacy and progression free survival (PFS) under the RecistTM, and the correlation between the efficacy of RecistTM criteria and ctDNA level.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'NSCLC patients with stage IIIB-IV，Driver gene positive， and any one of the tumor markers is more than three times higher than the normal level,', 'eligibilityCriteria': "Inclusion Criteria:\n\n* NSCLC patients with stage IIIB-IV\n* Driver gene positive (EGFR,ALK,C-MET, ROS,RET, HER2);\n* First line targeted therapy.\n* Performance status of 0-2 on the ECOG criteria.\n* Any one of the tumor markers is more than three times higher than the normal level, and the tumor markers include: CEA\\>15ng/ml,CA-199\\>105U/ml,CA-125\\>105 U/ml, NSE\\>60 ng/ml, SCCAg\\>7.5 ng/ml, CYFRA21-1\\>21 ng/ml, et al.\n* Measurable lesions present\n* Age\\>=18\n* Adequate hematologic (neutrophil count \\>= 1,500/uL, platelets \\>= 60,000/uL,hemoglobin≥70g/L), hepatic (transaminase =\\< upper normal limit(UNL)x2.5, bilirubin level =\\< UNLx1.5), and renal (creatinine =\\< UNL) function.\n* Informed consent from patient or patient's relative.\n\nExclusion Criteria:\n\n* Patients with dysphagia;\n* Unable to taking medication on time;\n* Patients with a history of abuse of psychotropic substances who are unable to quit or have mental disorders"}, 'identificationModule': {'nctId': 'NCT06142058', 'briefTitle': 'RecistTM Criteria in Evaluating the Efficacy of Targeted Therapy for NSCLC', 'organization': {'class': 'OTHER', 'fullName': 'Third Military Medical University'}, 'officialTitle': 'Application of the RecistTM Criteria in Evaluating the Efficacy of Targeted Therapy for Advanced Non-small Cell Lung Cancer With Positive Driving Genes', 'orgStudyIdInfo': {'id': 'RecistTM-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'RecistTM criteria', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['RECIST criteria'], 'description': 'RecistTM criteria and RECIST criteria were used to evaluate the efficacy of targeted therapy for NSCLC with positive driving gene.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '400042', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xueqin Yang, PH.D.', 'role': 'CONTACT', 'email': 'yangxueqin@hotmail.com', 'phone': '86-23-68757151'}, {'name': 'Xueqin Yang, PH.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cancer Center, Dapping Hospital, Army Medical Center of PLA', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Xueqin Yang, PhD', 'role': 'CONTACT', 'email': 'yangxueqin@hotmail.com', 'phone': '15923366936'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xueqin Yang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Xueqin Yang', 'investigatorAffiliation': 'Third Military Medical University'}}}}