Clinical trial · Interventional
Patient-Reported AutoImmunity Secondary to Cancer immunothErapy
NCT03849131CI-TRIAL-00087079PRAISEactive not recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Opportunistic Autoimmune Diseases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biological collection | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- incidence of severe autoimmune manifestations in patients treated with BMS checkpoint inhibitors.
- timeFrame
- 2 years after inclusion
- description
- 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
Secondary outcomes (10)
- measure
- Comparison of the age for the two groups of patients
- timeFrame
- 2 years after inclusion
- description
- Comparison of the age for the two groups of patients (one who develop severe autoimmune manifestations, one who does not develop severe autoimmune manifestations)
- measure
- Comparison of the gender for the two groups of patients
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.