Status:
ACTIVE_NOT_RECRUITING
Patient-Reported AutoImmunity Secondary to Cancer immunothErapy
Lead Sponsor:
University Hospital, Strasbourg, France
Conditions:
Opportunistic Autoimmune Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2025
Estimated Enrollment :
905 Patients enrolled
Trial Details
Trial ID
NCT03849131
Start Date
November 29 2019
End Date
June 1 2025
Last Update
March 12 2025
Active Locations (1)
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1
Hopitaux universitaires de strasbourg
Strasbourg, Alsace, France, 67000