Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT04923802
Status:
TERMINATED
Last Update Posted:
2024-03-08
First Post:
2021-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multi-Omics Testing for Immunotherapy Efficacy Evaluation (MOTIVATION)
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Unable to recruit sufficient numbers of patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-06', 'studyFirstSubmitDate': '2021-06-05', 'studyFirstSubmitQcDate': '2021-06-10', 'lastUpdatePostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival (PFS)', 'timeFrame': '2 years', 'description': 'Progression free survival (PFS) is defined as the period a participant remains alive without disease progression after study registration. Tumor status is assessed per the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) by computed tomography (CT), positron emission tomography (PET) CT and/or X rays.\n\nComplete Response (CR) = Disappearance of all lesions Partial Response (PR) = ≥30% decrease in the sum of the lesion diameters Overall Response (OR) = CR + PR Progressive disease (PD) = 20% increase in the sum of lesion diameters, and/or the appearance of 1+ new lesion(s) Stable disease (SD) = Small changes that do not meet any of the above criteria'}, {'measure': 'Disease-free survival (DFS)', 'timeFrame': '2 years', 'description': 'Disease-free survival (DFS) is defined as the number of participants remaining alive without disease progression (PD), symptomatic deterioration or death due to any cause. DFS is assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, as follows.\n\nComplete Response (CR) = Disappearance of all target lesions Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions Progressive disease (PD) = 20% increase in the sum of the diameters of target lesions (must be \\> 5 mm), unequivocal progression of non-target lesions, and/or the appearance of one or more new lesion(s) Stable disease (SD) = Small changes that do not meet any of the above criteria. The outcome will be reported as the number of participants who meet the criteria for DFS, a number without dispersion.'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': '2 years', 'description': 'Overall survival (OS) defined as the duration from study registration until death due to any cause. The outcome will be reported as the number of participants known to be alive at 24 months after study registration, a number without dispersion.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-small Cell Lung Cancer', 'Neoantigen', 'Next-generation Sequencing', 'Biomarker']}, 'descriptionModule': {'briefSummary': "This multicenter prospective observational and exploratory study aims to develop and validate a novel multi-omics-based computational method for neoantigen prediction in non-small cell lung cancer (NSCLC), and discover biomarkers for evaluation of PD-1/PD-L1 inhibitor's efficacy in patients of advanced NSCLC.", 'detailedDescription': 'Tumor tissues and blood samples from about 400 patients with non-small-cell lung cancer (NSCLC) will be collected for the study, which will be subject to NGS-based genomic, transcriptomic, and methylomic profiling in order to construct a multi-omics landscape of NSCLC. These multi-omics data will be used to construct and validate a novel computational method for neoantigen prediction. Additionally, biomarkers will be explored for prognosis and patient stratification, as well as for evaluation of PD-1/PD-L1 inhibitor treatment efficacy in patients of advanced NSCLC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with stage I-IV non-small cell lung cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with stage I-IV non-small cell lung cancer(with no restriction of age, gender, or smoking history)\n* Patients in the group will be allowed to collect whole blood and tissue samples at specific time points\n* Eastern Cooperative Oncology Group Performance Status of 0-1 within 28 days prior to registration\n* No previous systemic anti-tumor therapy\n* Signed informed consent\n\nExclusion Criteria:\n\n* Active or history of autoimmune disease or immune deficiency\n* Patients with serious mental disease\n* Prior allogeneic stem cell or solid organ transplantation\n* Pregnant or lactating women\n* Patients who cannot obtain tumor tissue samples and / or whole blood\n* Patients with history of blood transfusion within half a year\n* Patients with any other malignancy diagnosed within 5 years\n* Received systemic anti-tumor therapy'}, 'identificationModule': {'nctId': 'NCT04923802', 'acronym': 'MOTIVATION', 'briefTitle': 'Multi-Omics Testing for Immunotherapy Efficacy Evaluation (MOTIVATION)', 'organization': {'class': 'INDUSTRY', 'fullName': 'GeneCast Biotechnology Co., Ltd.'}, 'officialTitle': 'A Multicenter Prospective Observational Study of Non-small Cell Lung Cancer Patients for Development and Validation of Computational Method for Multi-omics-based Neoantigen Prediction and Biomarkers for Immunotherapy Response Evaluation', 'orgStudyIdInfo': {'id': 'MOTIVATION'}}, 'contactsLocationsModule': {'locations': [{'zip': '400000', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'Second Affiliated Hospital of Army Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'overallOfficials': [{'name': 'Bo Zhu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xinqiao Hospital of Chongqing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GeneCast Biotechnology Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Xinqiao Hospital of Chongqing', 'class': 'OTHER'}, {'name': 'Shanghai Pulmonary Hospital, Shanghai, China', 'class': 'OTHER'}, {'name': 'Shanghai Chest Hospital', 'class': 'OTHER'}, {'name': 'Wuhan University', 'class': 'OTHER'}, {'name': 'Renmin Hospital of Wuhan University', 'class': 'OTHER'}, {'name': 'Tongji Hospital', 'class': 'OTHER'}, {'name': 'Southwest Hospital, China', 'class': 'OTHER'}, {'name': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University', 'class': 'OTHER'}, {'name': "People's Hospital of Chongqing", 'class': 'OTHER'}, {'name': 'Sichuan Cancer Hospital and Research Institute', 'class': 'OTHER'}, {'name': 'The Second Affiliated Hospital of Kunming Medical University', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, {'name': 'The Affiliated Hospital Of Southwest Medical University', 'class': 'OTHER'}, {'name': "Guizhou Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}, {'name': 'Shanxi Provincial Cancer Hospital', 'class': 'UNKNOWN'}, {'name': 'First Hospital of China Medical University', 'class': 'OTHER'}, {'name': 'Fujian Provincial Hospital', 'class': 'OTHER'}, {'name': 'Peking University Shenzhen Hospital', 'class': 'OTHER'}, {'name': 'Affiliated Cancer Hospital of Shantou University Medical College', 'class': 'OTHER'}, {'name': 'The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}