Informations générales (source: ClinicalTrials.gov)
Patient-Reported AutoImmunity Secondary to Cancer immunothErapy (PRAISE)
Interventional
Phase 4
University Hospital, Strasbourg, France (Voir sur ClinicalTrials)
novembre 2019
novembre 2025
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Isabelle MONNET | 29/03/2024 01:29:09 | Contacter | ||
| HOPITAL NOVO | AL SHEIKH | 04/07/2024 11:05:04 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hopitaux universitaires de strasbourg - 67000 - Strasbourg - Alsace - France | Bertrand MENNECIER, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.
- 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