Autoantibodies Prevalence During Checkpoint Inhibitor Treatment

CHU de Reims

Status: Active, not recruiting

Conditions: Autoimmune Adverse Effects of Anti-neoplasic Drug

Treatments: Biological: Blood sample

Study type: Observational

Funder types: Other

Identifiers

NCT04220034

PA19123*

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 1 patient group

Patients receiving inhibitor checkpoint treatment

Description:

adult patients that will receive for the first time checkpoint inhibitor for a neoplasic disease in a center participating to the study

Treatment:

Biological: Blood sample