Patient-Reported AutoImmunity Secondary to Cancer immunothErapy

Last updated: March 10, 2025
Sponsor: University Hospital, Strasbourg, France
Overall Status: Active - Not Recruiting

Phase

4

Condition

Collagen Vascular Diseases

Connective Tissue Diseases

Treatment

Biological collection

Clinical Study ID

NCT03849131
6994
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

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

  • As this research will be funded by BMS, for the e-Cohort, we will consider onlypatients 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 SNDSwill be included for the healthcare database claims study.

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

  • French Healthcare insurance beneficiary, whatever the scheme is.

Exclusion

Exclusion Criteria:

  • Patients in all interventional clinical trials, with exclusion from other studiesspecifically 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

Total Participants: 905
Treatment Group(s): 1
Primary Treatment: Biological collection
Phase: 4
Study Start date:
November 29, 2019
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Hopitaux universitaires de strasbourg

    Strasbourg, Alsace 67000
    France

    Site Not Available

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