Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-30 @ 6:43 AM
Study NCT ID:
NCT04473703
Status:
UNKNOWN
Last Update Posted:
2020-07-16
First Post:
2020-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Adverse Reactions Related to Immune Checkpoint Inhibitor in NSCLC Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-15', 'studyFirstSubmitDate': '2020-07-14', 'studyFirstSubmitQcDate': '2020-07-15', 'lastUpdatePostDateStruct': {'date': '2020-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Adverse Cardiovascular Events', 'timeFrame': '1 year', 'description': 'a) Primary Outcome is Major Adverse Cardiovascular Events（MACE）related to ICIs，includes: cardiovascular death, myocardial infarction(nonfatal), stroke(nonfatal), heart failure that caused readmission'}], 'secondaryOutcomes': [{'measure': 'Common Terminology Criteria for Adverse Events (CTCAE)', 'timeFrame': '1 year', 'description': 'Common Terminology Criteria for Adverse Events (CTCAE) related to ICIs, includes: arrhythmia, cardiogenic chest pain, valvular heart disease, cardiomyopathy, myocardial pericardial disease'}, {'measure': 'All cause of death', 'timeFrame': '1 year', 'description': "every reason that cause patient's death after ICIs treatment"}, {'measure': 'examination indexes', 'timeFrame': '1 year', 'description': 'The examination indexes that related to myocardial damage'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adverse Reactions', 'Immune Checkpoint Inhibitor', 'Non-Small Cell Lung Cancer Patients', 'Cardiac Event']}, 'descriptionModule': {'briefSummary': 'This is a prospective, open label, single arm study. A total of 300 patients with primary non-small cell lung cancer treated with PD-1/PD-L1 immune checkpoint inhibitors(ICIs) are expected to included . All patients will follow up for at least 1 year. Patients with cardiac adverse reactions after PD-1/PD-L1 immune checkpoint inhibitor treatment at admission or during the subsequently follow-up period will randomly assigned a random number to each patient by computer random sequence. Patients with odd random number will treat with RASI（renin-angiotensin system inhibitors）, and those with even random number will treat with ARNI（angiotensin-receptor-neprilysin inhibitor）.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 300 patients with primary non-small cell lung cancer treated with PD-1/PD-L1 immune checkpoint inhibitors(ICIs) are expected to included. And then the basic information and the examination results will be collected.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Be willing and able to provide written informed consent/assent for the trial;\n2. Lung cancer patients whose pathological results confirmed is primary non-small cell lung cancer, stage III\\~IV;\n3. Patients received with ICIs treatment, including anti-PD-1 or anti-PD-L1 for at least two courses;\n\nExclusion Criteria:\n\n1. Patients who do not have pathological diagnosis;\n2. Patients who can't finish the follow-up;\n3. The anti-PD-1, anti-PD-L1 therapy was less than two courses;\n4. Patients whose cancer diagnosed with small cell lung cancer."}, 'identificationModule': {'nctId': 'NCT04473703', 'briefTitle': 'Cardiac Adverse Reactions Related to Immune Checkpoint Inhibitor in NSCLC Patients', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Chest Hospital'}, 'officialTitle': 'A Prospective Study of Cardiac Adverse Reactions Related to Immune Checkpoint Inhibitor in Non-Small Cell Lung Cancer Patients', 'orgStudyIdInfo': {'id': 'SHXKYY202005'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'observation group', 'description': 'A total of 300 patients are expected to include in this group. And the cardiac adverse reactions related to immune checkpoint inhibitor will be observed.', 'interventionNames': ['Drug: renin-angiotensin system inhibitors or angiotensin-receptor-neprilysin inhibitor']}], 'interventions': [{'name': 'renin-angiotensin system inhibitors or angiotensin-receptor-neprilysin inhibitor', 'type': 'DRUG', 'description': 'Patients with odd random number will treat with RASI（renin-angiotensin system inhibitors）, and those with even random number will treat with ARNI（angiotensin-receptor-neprilysin inhibitor）', 'armGroupLabels': ['observation group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yunhua Xu', 'role': 'CONTACT', 'email': 'yhxu@shchest.org', 'phone': '86-021-22200000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Chest Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician', 'investigatorFullName': 'Xumin Hou', 'investigatorAffiliation': 'Shanghai Chest Hospital'}}}}