Trials / Completed
CompletedNCT04220034
Autoantibodies Prevalence During Checkpoint Inhibitor Treatment
Autoantibodies Prevalence and Their Related-diseases During Checkpoint Inhibitor Treatment
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 183 (actual)
- Sponsor
- CHU de Reims · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2020-01-15
- Primary completion
- 2024-07-22
- Completion
- 2025-11-28
- First posted
- 2020-01-07
- Last updated
- 2025-12-02
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04220034. Inclusion in this directory is not an endorsement.