Clinical trial
Autoantibodies Prevalence and Their Related-diseases During Checkpoint Inhibitor Treatment
Name
PA19123*
Description
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.
To 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.
Trial arms
Trial start
2020-01-15
Estimated PCD
2024-01-15
Trial end
2024-07-15
Status
Active (not recruiting)
Treatment
Blood sample
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
Arms:
Patients receiving inhibitor checkpoint treatment
Size
150
Primary endpoint
development or increase level of anti-nuclear antibody
Month 6
development or increase level of anti-cyclic citrullinated peptide antibodies
Month 6
development or increase level of rheumatoid factor
Month 6
development or increase level of Anti-glutamic acid decarboxylase antibodies
Month 6
development or increase level of Anti-thyroperoxydase antibodies
Month 6
development or increase level of Auto-antibodies associated with myositis
Month 6
Eligibility criteria
Inclusion Criteria:
* patients receiving check point inhibitor for a neoplasic disease in a center that participates to the study during the inclusion period
* patients who agree to participate in the study
* adult patients (aged more than 18 years old)
Exclusion Criteria:
- previous treatment with check point inhibitor
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood sample'}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}
Updated at
2024-04-15
1 organization
1 indication
Organization
Centre hospitalier universitaire de Reims