Patient-Reported AutoImmunity Secondary to Cancer immunothErapy (PRAISE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Opportunistic Autoimmune Diseases
• Intervention / Treatment: Biological: Biological collection

• Study Type: Interventional
• Enrollment (Actual): 905
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Alsace
    • Strasbourg, Alsace, France, 67000
      • Hôpitaux Universitaires de Strasbourg

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of severe autoimmune manifestations in patients treated with BMS checkpoint inhibitors.	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	2 years after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the age for the two groups of patients	Comparison of the age for the two groups of patients (one who develop severe autoimmune manifestations, one who does not develop severe autoimmune manifestations)	2 years after inclusion
Comparison of the gender for the two groups of patients	Comparison of the gender for the two groups of patients (one who develop severe autoimmune manifestations, one who does not develop severe autoimmune manifestations)	2 years after inclusion
Comparison of the body-mass index for the two groups of patients	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)	2 years after inclusion
Comparison of the types of cancer for the two groups of patients	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)	2 years after inclusion
Comparison of the number of previous lines of chemotherapy for the two groups of patients	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)	2 years after inclusion
Event-free survival of patients	Time that passes before first appearance of Opportunistic Autoimmunity Secondary to cancer Immunotherapy. The baseline is the onset of cancer immunotherapy.	2 years after inclusion
Description of flares or worsening of pre-existing autoimmune diseases	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)	2 years after inclusion
Comparison of baseline predictive factors of autoimmune manifestations for the two groups of patients	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)	2 years after inclusion
Changes in patients' quality of life over time and the impacts of OASI	EQ-5D-5L general quality of life scores	2 years after inclusion
Changes in patients' quality of life over time and the impacts of OASI	EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire)	2 years after inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Jacques-Eric GOTTENBERG, MD, PhD, University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2019
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: January 9, 2019
• First Submitted That Met QC Criteria: February 19, 2019
• First Posted (Actual): February 21, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: oncology; checkpoint inhibitors; patient reported outcome; monoclonal anti-PD-1 immunotherapy; monoclonal anti-CTLA-4 immunotherapy; autoimmune manifestations
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases
• Other Study ID Numbers: 6994

Drug and device information, study documents

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