Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 11:09 PM
Study NCT ID:
NCT04220034
Status:
COMPLETED
Last Update Posted:
2025-12-02
First Post:
2020-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autoantibodies Prevalence During Checkpoint Inhibitor Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 183}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-11-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-28', 'studyFirstSubmitDate': '2020-01-03', 'studyFirstSubmitQcDate': '2020-01-03', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'development or increase level of anti-nuclear antibody', 'timeFrame': 'Month 6', 'description': 'Development of anti-nuclear antibody will be defined by detection of autoantibodies above the positive threshold of the test if below the positive threshold initially (seroconversion) Increase level of anti-nuclear antibody will be defined by increase of at least 2 dilutions of the antibody titer'}, {'measure': 'development or increase level of anti-cyclic citrullinated peptide antibodies', 'timeFrame': 'Month 6', 'description': 'Development of anti-cyclic citrullinated peptide antibodies will be defined by detection of autoantibodies above the positive threshold of the test if below the positive threshold initially (seroconversion) Increase level of anti-cyclic citrullinated peptide antibodies will be defined by doubling the concentration of the antibody titer'}, {'measure': 'development or increase level of rheumatoid factor', 'timeFrame': 'Month 6', 'description': 'Development of rheumatoid factor will be defined by detection of autoantibodies above the positive threshold of the test if below the positive threshold initially (seroconversion) Increase level of rheumatoid factor will be defined by doubling the concentration of the antibody titer'}, {'measure': 'development or increase level of Anti-glutamic acid decarboxylase antibodies', 'timeFrame': 'Month 6', 'description': 'Development of Anti-glutamic acid decarboxylase antibodies will be defined by detection of autoantibodies above the positive threshold of the test if below the positive threshold initially (seroconversion) Increase level of Anti-glutamic acid decarboxylase antibodies will be defined by doubling the concentration of the antibody titer'}, {'measure': 'development or increase level of Anti-thyroperoxydase antibodies', 'timeFrame': 'Month 6', 'description': 'Development of anti-TSH receptor antibodies will be defined by detection of autoantibodies above the positive threshold of the test if below the positive threshold initially (seroconversion) Increase level of anti-TSH receptor antibodies will be defined by doubling the concentration of the antibody titer'}, {'measure': 'development or increase level of Auto-antibodies associated with myositis', 'timeFrame': 'Month 6', 'description': 'Development of Auto-antibodies associated with myositis antibodies will be defined by detection of autoantibodies above the positive threshold of the test if below the positive threshold initially (seroconversion) Increase level of Auto-antibodies associated with myositis antibodies will be defined by doubling the concentration of the antibody titer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autoimmune Adverse Effects of Anti-neoplasic Drug']}, 'descriptionModule': {'briefSummary': 'The use of Checkpoint inhibitors (ICIs) is rapidly expanding to the treatment of many cancer types. Autoimmunity and clinical autoimmune diseases represent adverse events of ICIs with variable severity and consequences. Clinical trials using ICIs have largely excluded patients with preexisting autoimmune diseases but the rate of autoimmune flares has been reported to be high in patients with preexisting autoimmune diseases in retrospective cohort studies. Moreover numerous retrospective cases and series reported ICI-related autoimmune diseases in patients without any previous autoimmune event.\n\nTo date, no study has prospectively evaluated the rate of biological and clinical autoimmunity in patients. Moreover, guidelines concerning autoantibodies monitoring in patients are subject of debate.', 'detailedDescription': 'The aim of this prospective study is to determine development or increase level frequencies of different types of autoantibodies in patients receiving ICI for the first time. The rate of clinical autoimmunes diseases development will also be recorded and correlated with autoantibodies prevalence before and during ICI treatment.\n\nResults will help to determine the rate of biological and clinical autoimmune events induced by ICIs in unselected patients and will help to clarify autoimmunity screening strategy in this setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving inhibitor checkpoint treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients receiving check point inhibitor for a neoplasic disease in a center that participates to the study during the inclusion period\n* patients who agree to participate in the study\n* adult patients (aged more than 18 years old)\n\nExclusion Criteria:\n\n\\- previous treatment with check point inhibitor'}, 'identificationModule': {'nctId': 'NCT04220034', 'briefTitle': 'Autoantibodies Prevalence During Checkpoint Inhibitor Treatment', 'organization': {'class': 'OTHER', 'fullName': 'CHU de Reims'}, 'officialTitle': 'Autoantibodies Prevalence and Their Related-diseases During Checkpoint Inhibitor Treatment', 'orgStudyIdInfo': {'id': 'PA19123*'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients receiving inhibitor checkpoint treatment', 'description': 'adult patients that will receive for the first time checkpoint inhibitor for a neoplasic disease in a center participating to the study', 'interventionNames': ['Biological: Blood sample']}], 'interventions': [{'name': 'Blood sample', 'type': 'BIOLOGICAL', 'description': 'Blood sample will be collected to determine development or increase level frequencies of different types of autoantibodies in patients receiving ICI for the first time', 'armGroupLabels': ['Patients receiving inhibitor checkpoint treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51092', 'city': 'Reims', 'country': 'France', 'facility': 'Chu Reims', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHU de Reims', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}