Autoantibodies Prevalence During Checkpoint Inhibitor Treatment
- Conditions
- Autoimmune Adverse Effects of Anti-neoplasic Drug
- Interventions
- Biological: Blood sample
- Registration Number
- NCT04220034
- Lead Sponsor
- CHU de Reims
- Brief Summary
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.
- Detailed Description
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.
Results 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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)
- previous treatment with check point inhibitor
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients receiving inhibitor checkpoint treatment Blood sample adult patients that will receive for the first time checkpoint inhibitor for a neoplasic disease in a center participating to the study
- Primary Outcome Measures
Name Time Method development or increase level of rheumatoid factor Month 6 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
development or increase level of anti-nuclear antibody Month 6 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
development or increase level of Anti-thyroperoxydase antibodies Month 6 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
development or increase level of anti-cyclic citrullinated peptide antibodies Month 6 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
development or increase level of Anti-glutamic acid decarboxylase antibodies Month 6 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
development or increase level of Auto-antibodies associated with myositis Month 6 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Chu Reims
🇫🇷Reims, France