Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 11:09 PM
Study NCT ID:
NCT04220034
Status:
COMPLETED
Last Update Posted:
2025-12-02
First Post:
2020-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autoantibodies Prevalence During Checkpoint Inhibitor Treatment
Sponsor:
CHU de Reims
Organization:
Study Overview
Official Title:
Autoantibodies Prevalence and Their Related-diseases During Checkpoint Inhibitor Treatment
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: