Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-25 @ 8:04 PM
Study NCT ID:
NCT05352035
Status:
RECRUITING
Last Update Posted:
2025-04-30
First Post:
2022-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multiomics Tumor Evolution Model of 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': 'tumor tissue and blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-27', 'studyFirstSubmitDate': '2022-04-23', 'studyFirstSubmitQcDate': '2022-04-23', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free survival (DFS)', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'Time from randomization to disease recurrence or death from any cause.'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'Time from randomization to death from any cause.'}], 'secondaryOutcomes': [{'measure': 'Relationship between translational biomarkers and clinical outcome', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'To evaluate if the translational biomarkers can be prediction tools for the clinical outcomes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-small cell lung cancer', 'Multiomics analysis', 'Tumor evolution', 'Tumor immune microenvironment', 'Circulating tumor DNA', 'Radiomics', 'Prognostic model'], 'conditions': ['Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the evolutionary mechanism of early-stage non-small cell lung cancer and establish an accurate prognostic model and a recurrence monitoring system by multiomics analysis, which can be helpful for the individual and whole management of lung cancer patients and improve the overall prognosis.', 'detailedDescription': 'Lung cancer is the leading cause of cancer-related death globally. Non-small cell lung cancer (NSCLC) accounts for 85% of lung cancer and surgery is still the main treatment strategy. This study will determine the evolutionary mechanism of early-stage non-small cell lung cancer and establish an accurate prognostic model and a recurrence monitoring system by multiomics analysis, which can be helpful for the individual and whole management of lung cancer patients and improve the overall prognosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who meet the eligibility criteria will be included consecutively.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years old;\n2. Early-stage NSCLC patients underwent radical surgical resection;\n3. Sufficient tumor tissue and blood sample for study use;\n4. Available clinical-pathologic data, imaging data and follow-up date;\n5. Written informed consent.\n\nExclusion Criteria:\n\n1. History of other malignant tumors;\n2. Evidence of distant metastasis before surgery;\n3. Insufficient tumor tissue or blood sample for study use;\n4. Clinical-pathologic data, imaging data or follow-up date is not available;\n5. Other judgments by the Investigator that the patient should not participate in the study.'}, 'identificationModule': {'nctId': 'NCT05352035', 'briefTitle': 'Multiomics Tumor Evolution Model of NSCLC', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'A Multiomics Study of Tumor Evolution Characteristics and Prognostic Model in Early-stage Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': '2021-I2M-5-002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prospective cohort', 'description': 'This cohort will enroll a total of 300 patients prospectively'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Kezhong Chen', 'role': 'CONTACT', 'email': 'chenkezhong@pkuph.edu.cn', 'phone': '+86-010-88326657'}, {'name': 'Wenxiang Wang', 'role': 'CONTACT', 'email': 'wangwenxiang@stu.pku.edu.cn', 'phone': '+86-010-88326657'}, {'name': 'Jun Wang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Kezhong Chen, M.D.', 'role': 'CONTACT', 'email': 'chenkezhong@pkuph.edu.cn', 'phone': '+86-010-88326657'}, {'name': 'Wenxiang Wang', 'role': 'CONTACT', 'email': 'wangwenxiang@stu.pku.edu.cn', 'phone': '+86-010-88326657'}], 'overallOfficials': [{'name': 'Jun Wang', 'role': 'STUDY_CHAIR', 'affiliation': "Peking University People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Research Unit of Intelligence Diagnosis and treatment of early-stage non-small cell lung cancer, Chinese Academy of Medical Sciences', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Member of the Chinese Academy of Engineering', 'investigatorFullName': 'Jun Wang', 'investigatorAffiliation': "Peking University People's Hospital"}}}}