Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03849131

Patient-Reported AutoImmunity Secondary to Cancer immunothErapy

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Opportunistic Autoimmune Diseases Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hopitaux universitaires de strasbourg

Strasbourg, Alsace, 67000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biological collection

Biological

Blood samples will be collected only once at enrollment, before initiation of a checkpoint inhibitor.

It will include:

  • DNA samples collection
  • RNA samples collection
  • Blood sample collection

Other names: Biobank

Primary outcomes

  1. incidence of severe autoimmune manifestations in patients treated with BMS checkpoint inhibitors.

    Time frame: 2 years after inclusion

    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

  1. Comparison of the age for the two groups of patients

    Time frame: 2 years after inclusion

    Comparison of the age for the two groups of patients (one who develop severe autoimmune manifestations, one who does not develop severe autoimmune manifestations)

  2. Comparison of the gender for the two groups of patients

    Time frame: 2 years after inclusion

    Comparison of the gender for the two groups of patients (one who develop severe autoimmune manifestations, one who does not develop severe autoimmune manifestations)

  3. Comparison of the body-mass index for the two groups of patients

    Time frame: 2 years after inclusion

    Comparison of the body-mass index for the two groups of patients (one who develop severe autoimmune manifestations, one who does not develop severe autoimmune manifestations)

  4. Comparison of the types of cancer for the two groups of patients

    Time frame: 2 years after inclusion

    Comparison of the types of cancer for the two groups of patients (one who develop severe autoimmune manifestations, one who does not develop severe autoimmune manifestations)

  5. Comparison of the number of previous lines of chemotherapy for the two groups of patients

    Time frame: 2 years after inclusion

    Comparison of the number of previous lines of chemotherapy for the two groups of patients (one who develop severe autoimmune manifestations, one who does not develop severe autoimmune manifestations)

  6. Event-free survival of patients

    Time frame: 2 years after inclusion

    Time that passes before first appearance of Opportunistic Autoimmunity Secondary to cancer Immunotherapy. The baseline is the onset of cancer immunotherapy.

  7. Description of flares or worsening of pre-existing autoimmune diseases

    Time frame: 2 years after inclusion

    Pre-existing autoimmune disease will be defined by expert judgement on history of autoimmunity ongoing activity and blood analysis (preexisting autoantibodies will be investigated using biobanked serum)

  8. Comparison of baseline predictive factors of autoimmune manifestations for the two groups of patients

    Time frame: 2 years after inclusion

    Assessment of the prevalence of preexisting autoantibodies before immune checkpoint inhibitor initiation for the two groups of patients (one who develop severe autoimmune manifestations, one who does not develop severe autoimmune manifestations)

  9. Changes in patients' quality of life over time and the impacts of OASI

    Time frame: 2 years after inclusion

    EQ-5D-5L general quality of life scores

  10. Changes in patients' quality of life over time and the impacts of OASI

    Time frame: 2 years after inclusion

    EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire)

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: PRAISE

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Feb 21, 2019
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.