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Autoantibodies Prevalence During Checkpoint Inhibitor Treatment

NCT04220034 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 183

Last updated 2025-12-02

No results posted yet for this study

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.

Conditions

  • Autoimmune Adverse Effects of Anti-neoplasic Drug

Interventions

BIOLOGICAL

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

Sponsors & Collaborators

  • CHU de Reims

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-15
Primary Completion
2024-07-22
Completion
2025-11-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04220034 on ClinicalTrials.gov