Autoantibodies Prevalence During Checkpoint Inhibitor Treatment

Autoantibodies Prevalence and Their Related-diseases 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.

Study Overview

• Status: Completed
• Conditions: Autoimmune Adverse Effects of Anti-neoplasic Drug
• Intervention / Treatment: Biological: Blood sample

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.

• Study Type: Observational
• Enrollment (Actual): 183

Contacts and Locations

Study Locations

• France
  • Reims, France, 51092
    • CHU Reims

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients receiving inhibitor checkpoint treatment

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients receiving inhibitor checkpoint treatment; adult patients that will receive for the first time checkpoint inhibitor for a neoplasic disease in a center participating to the study	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: CHU de Reims

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2020
• Primary Completion (Actual): July 22, 2024
• Study Completion (Actual): November 28, 2025

Study Registration Dates

• First Submitted: January 3, 2020
• First Submitted That Met QC Criteria: January 3, 2020
• First Posted (Actual): January 7, 2020

Study Record Updates

• Last Update Posted (Estimated): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 28, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: PA19123*

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No