Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT05288569
Status:
UNKNOWN
Last Update Posted:
2023-04-07
First Post:
2022-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
irAE Prediction of Anti-PD-1/L1 in Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'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': 'plasma and peripheral monocytes obtained from the peripheral blood sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-05', 'studyFirstSubmitDate': '2022-03-11', 'studyFirstSubmitQcDate': '2022-03-18', 'lastUpdatePostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'occurrence of immune-related adverse event (irAE)', 'timeFrame': '12 months since immunotherapy initiation', 'description': 'Any adverse events occured within 12 months since immunotherapy initiation will be independently evaluated by two clinicians to determine whether it is irAE and all the clinical characteristics of irAE will be documented'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '24 months since immunotherapy initiation', 'description': 'Patients will be followed up for 2 years to investigate Overall Survival'}, {'measure': 'Progression Free Survival.', 'timeFrame': '24 months since immunotherapy initiation', 'description': 'Patients will be followed up for 2 years to investigate Progression Free Survival.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['immunology', 'biomarkers', 'prediction', 'multidimensional'], 'conditions': ['Immune Checkpoint Inhibitors', 'Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '32135278', 'type': 'BACKGROUND', 'citation': 'Yang H, Yao Z, Zhou X, Zhang W, Zhang X, Zhang F. Immune-related adverse events of checkpoint inhibitors: Insights into immunological dysregulation. Clin Immunol. 2020 Apr;213:108377. doi: 10.1016/j.clim.2020.108377. Epub 2020 Mar 2.'}]}, 'descriptionModule': {'briefSummary': 'the purpose of this study is to identify multi-dimensional immunological biomarkers including cytokines, autoantibodies, and immune cell subtypes of immune-related adverse events (primary) and prognosis(secondary) in the anti-PD-1/anti-PD-L1 immunotherapy for lung cancer', 'detailedDescription': 'After being informed of the study and potential risk, all patients giving written informed consent will undergo peripheral blood sample collection at baseline (before treatment ), 1month and 3month after treatment initiation, and when immune-related adverse events ever occur. The follow-up period will be 1 year for any occurrence of immune-related adverse events and 2 years follow-up for the prognosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients at a national tertiary referral center for lung cancer treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-80 years of age\n* Stage I-IV Lung Cancer confirmed by histopathology or imaging techniques\n* Receiving anti-PD-1/anti-PD-L1 immunotherapy (with indication and no contraindication)\n\nExclusion Criteria:\n\n* Other cancer treatment\n* Other malignancies'}, 'identificationModule': {'nctId': 'NCT05288569', 'briefTitle': 'irAE Prediction of Anti-PD-1/L1 in Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Immunological Biomarkers for Immune-related Adverse Events of Anti-PD-1/PD-L1 Immunotherapy in Lung Cancer: a Prediction Model', 'orgStudyIdInfo': {'id': 'JS-2853'}}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huaxia Yang', 'role': 'CONTACT', 'email': 'yanghuaxia2003@163.com', 'phone': '+86-13488869596'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Huaxia Yang', 'role': 'CONTACT', 'email': 'yanghuaxia2013@163.com', 'phone': '+86-13488869596'}], 'overallOfficials': [{'name': 'Huaxia Yang', 'role': 'STUDY_CHAIR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}