Patient-Reported AutoImmunity Secondary to Cancer immunothErapy

Phase 4

Active, not recruiting

• Conditions: Opportunistic Autoimmune Diseases

• Registration Number: NCT03849131
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

This is a real life observational longitudinal study aiming to identify autoimmune manifestations in patients treated with "checkpoint inhibitors" in mono or combo therapy in real life.

The study is based on patients reported experience validated by physician, recruited in cancer centers in France with another data collection from a French healthcare data claims database and a biological collection.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-09
• Study First Submitted QC: 2019-02-19
• Study First Posted: 2019-02-21
• Study Start: 2019-11-29
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 905

Inclusion Criteria

• Adult patient (over 18 year old) in France (DOM/TOM included), starting a monoclonal anti-PD-1 and/or anti-CTLA-4 immunotherapy for a cancer, whatever the cancer, within the Marketing Authorization.

  • As this research will be funded by BMS, for the e-Cohort, we will consider only patients treated by a BMS monoclonal antibody, to date: Ipilimumab (YERVOY©), Nivolumab (OPDIVO©) and Combo according to SmPCs.
  • All patients (anonymous) with a reimbursed checkpoint inhibitor drug in SNDS will be included for the healthcare database claims study.

• Included patients should be able to understand and fill in questionnaires in French and should give informed consent and contact details, they should be able to read and answer emails in French.

  • French Healthcare insurance beneficiary, whatever the scheme is.

Exclusion Criteria

• Patients in all interventional clinical trials, with exclusion from other studies specifically mentioned
• Patients deprived of liberty or guardianship
• Women of childbearing potential with a desire of becoming pregnant
• Major patients under tutorship.
• Patients with dementia or drug addiction
• Patients with no regular access to internet and phone

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
incidence of severe autoimmune manifestations in patients treated with BMS checkpoint inhibitors.	2 years after inclusion	Severe autoimmune manifestations is defined by : * Discontinuation (temporary or definitive) of the cancer immunotherapy related to Autoimmunity; * or requirement for treatment due to auto-immune manifestations according to expert judgement; * or hospitalization for autoimmune manifestations; * or death related to autoimmune manifestations

Secondary Outcome Measures

Name	Time	Method
Comparison of the body-mass index for the two groups of patients	2 years after inclusion	Comparison of the body-mass index for the two groups of patients (one who develop severe autoimmune manifestations, one who does not develop severe autoimmune manifestations)
Comparison of the gender for the two groups of patients	2 years after inclusion	Comparison of the gender for the two groups of patients (one who develop severe autoimmune manifestations, one who does not develop severe autoimmune manifestations)
Comparison of the types of cancer for the two groups of patients	2 years after inclusion	Comparison of the types of cancer for the two groups of patients (one who develop severe autoimmune manifestations, one who does not develop severe autoimmune manifestations)
Comparison of the number of previous lines of chemotherapy for the two groups of patients	2 years after inclusion	Comparison of the number of previous lines of chemotherapy for the two groups of patients (one who develop severe autoimmune manifestations, one who does not develop severe autoimmune manifestations)
Event-free survival of patients	2 years after inclusion	Time that passes before first appearance of Opportunistic Autoimmunity Secondary to cancer Immunotherapy. The baseline is the onset of cancer immunotherapy.
Comparison of baseline predictive factors of autoimmune manifestations for the two groups of patients	2 years after inclusion	Assessment of the prevalence of preexisting autoantibodies before immune checkpoint inhibitor initiation for the two groups of patients (one who develop severe autoimmune manifestations, one who does not develop severe autoimmune manifestations)
Changes in patients' quality of life over time and the impacts of OASI	2 years after inclusion	EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire)
Description of flares or worsening of pre-existing autoimmune diseases	2 years after inclusion	Pre-existing autoimmune disease will be defined by expert judgement on history of autoimmunity ongoing activity and blood analysis (preexisting autoantibodies will be investigated using biobanked serum)
Comparison of the age for the two groups of patients	2 years after inclusion	Comparison of the age for the two groups of patients (one who develop severe autoimmune manifestations, one who does not develop severe autoimmune manifestations)

Trial Locations

Locations (1)

Hopitaux universitaires de strasbourg; 🇫🇷 Strasbourg, Alsace, France