Autoimmune Adverse Effects of Anti-neoplasic Drug Clinical Trial
Official title:
Autoantibodies Prevalence and Their Related-diseases During Checkpoint Inhibitor Treatment
| Verified date | April 2024 |
| Source | CHU de Reims |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Active, not recruiting |
| Enrollment | 150 |
| Est. completion date | July 15, 2024 |
| Est. primary completion date | January 15, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Chu Reims | Reims |
| Lead Sponsor | Collaborator |
|---|---|
| CHU de Reims |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | development or increase level of anti-nuclear antibody | 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 | Month 6 | |
| Primary | development or increase level of anti-cyclic citrullinated peptide antibodies | 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 | Month 6 | |
| Primary | development or increase level of rheumatoid factor | 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 | Month 6 | |
| Primary | development or increase level of Anti-glutamic acid decarboxylase antibodies | 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 | Month 6 | |
| Primary | development or increase level of Anti-thyroperoxydase antibodies | 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 | Month 6 | |
| Primary | development or increase level of Auto-antibodies associated with myositis | 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 | Month 6 |