Patient-Reported AutoImmunity Secondary to Cancer immunothErapy (PRAISE)

University Hospital, Strasbourg, France

Status and phase: Active, not recruiting; Phase 4

Conditions: Opportunistic Autoimmune Diseases

Treatments: Biological: Biological collection

Study type: Interventional

Funder types: Other

Identifiers

NCT03849131

6994

Details and patient eligibility

About

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.

Enrollment: 905 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)