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Clinical Trials in France / NCT03849131
Active, not recruiting Phase 4

Patient-Reported AutoImmunity Secondary to Cancer immunothErapy

NCT03849131 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Strasbourg, France
Phase
Phase 4
Started
2019-11-29
Last updated
2025-03-12

Condition(s) studied

Opportunistic Autoimmune Diseases

Investigational drug(s) / intervention(s)

Biological collection →

Biological collection: 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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Hopitaux universitaires de strasbourg Strasbourg Alsace

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03849131 on ClinicalTrials.gov ↗ ← All trials in France