Patient-Reported AutoImmunity Secondary to Cancer immunothErapy

Phase 4Active Not RecruitingNCT03849131

University Hospital, Strasbourg, France905 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

905

Conditions

Opportunistic Autoimmune Diseases

Interventions

Biological collectionBIOLOGICAL

Blood samples will be collected only once at enrollment, before initiation of a checkpoint inhibitor. It will include: * DNA samples collection * RNA samples collection * Blood sample collection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hopitaux universitaires de strasbourg

Strasbourg, Alsace, France

Outcomes

Primary Outcomes

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