PRAISE: Patient-Reported AutoImmunity Secondary to Cancer immunothErapy

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT03849131
Collaborator
(none)
900
1
71.1
12.7

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Biological collection
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
900 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Patient-Reported AutoImmunity Secondary to Cancer immunothErapy
Actual Study Start Date :
Nov 29, 2019
Anticipated Primary Completion Date :
Nov 1, 2025
Anticipated Study Completion Date :
Nov 1, 2025

Outcome Measures

Primary Outcome Measures

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

  1. Comparison of the age for the two groups of patients [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 [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 [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 [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 [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 [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 [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 [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 [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 [2 years after inclusion]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hopitaux universitaires de strasbourg Strasbourg Alsace France 67000

Sponsors and Collaborators

  • University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Jacques-Eric GOTTENBERG, MD, PhD, University Hospital, Strasbourg, France

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT03849131
Other Study ID Numbers:
  • 6994
First Posted:
Feb 21, 2019
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Strasbourg, France
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2022