Chu Reims
Reims, 51092, France
Completed
NCT Number: NCT04220034
Autoantibodies Prevalence During Checkpoint Inhibitor Treatment
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.
Completed
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Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Blood sample
BiologicalBlood sample will be collected to determine development or increase level frequencies of different types of autoantibodies in patients receiving ICI for the first time
Primary outcomes
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development or increase level of anti-nuclear antibody
Time frame: 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-cyclic citrullinated peptide antibodies
Time frame: 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 rheumatoid factor
Time frame: 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-glutamic acid decarboxylase antibodies
Time frame: 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 Anti-thyroperoxydase antibodies
Time frame: 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 Auto-antibodies associated with myositis
Time frame: 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
Sponsors and collaborators
Lead sponsor
CHU de Reims
Other
Registry information
Official study title
Autoantibodies Prevalence and Their Related-diseases During Checkpoint Inhibitor Treatment
Important dates
- Study start
- 2020
- Primary completion
- 2024
- Study completion
- 2025
- First posted
- Jan 7, 2020
- Registry last updated
- Dec 2, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.