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Patient-Reported AutoImmunity Secondary to Cancer immunothErapy (PRAISE)

Primary Purpose

Opportunistic Autoimmune Diseases

Status
Recruiting
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Biological collection
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opportunistic Autoimmune Diseases focused on measuring monoclonal anti-PD-1 immunotherapy, monoclonal anti-CTLA-4 immunotherapy, checkpoint inhibitors, autoimmune manifestations, patient reported outcome, oncology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hopitaux universitaires de strasbourgRecruiting

Outcomes

Primary Outcome Measures

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

Comparison of the age for the two groups of patients
Comparison of the age for the two groups of patients (one who develop severe autoimmune manifestations, one who does not develop severe autoimmune manifestations)
Comparison of the gender for the two groups of patients
Comparison of the gender for the two groups of patients (one who develop severe autoimmune manifestations, one who does not develop severe autoimmune manifestations)
Comparison of the body-mass index for the two groups of patients
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)
Comparison of the types of cancer for the two groups of patients
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)
Comparison of the number of previous lines of chemotherapy for the two groups of patients
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)
Event-free survival of patients
Time that passes before first appearance of Opportunistic Autoimmunity Secondary to cancer Immunotherapy. The baseline is the onset of cancer immunotherapy.
Description of flares or worsening of pre-existing autoimmune diseases
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)
Comparison of baseline predictive factors of autoimmune manifestations for the two groups of patients
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)
Changes in patients' quality of life over time and the impacts of OASI
EQ-5D-5L general quality of life scores
Changes in patients' quality of life over time and the impacts of OASI
EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire)

Full Information

First Posted
January 9, 2019
Last Updated
August 17, 2022
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT03849131
Brief Title
Patient-Reported AutoImmunity Secondary to Cancer immunothErapy
Acronym
PRAISE
Official Title
Patient-Reported AutoImmunity Secondary to Cancer immunothErapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2019 (Actual)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opportunistic Autoimmune Diseases
Keywords
monoclonal anti-PD-1 immunotherapy, monoclonal anti-CTLA-4 immunotherapy, checkpoint inhibitors, autoimmune manifestations, patient reported outcome, oncology

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
900 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Biological collection
Other Intervention Name(s)
Biobank
Intervention Description
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
Primary Outcome Measure Information:
Title
incidence of severe autoimmune manifestations in patients treated with BMS checkpoint inhibitors.
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
Time Frame
2 years after inclusion
Secondary Outcome Measure Information:
Title
Comparison of the age for the two groups of patients
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)
Time Frame
2 years after inclusion
Title
Comparison of the gender for the two groups of patients
Description
Comparison of the gender for the two groups of patients (one who develop severe autoimmune manifestations, one who does not develop severe autoimmune manifestations)
Time Frame
2 years after inclusion
Title
Comparison of the body-mass index for the two groups of patients
Description
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)
Time Frame
2 years after inclusion
Title
Comparison of the types of cancer for the two groups of patients
Description
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)
Time Frame
2 years after inclusion
Title
Comparison of the number of previous lines of chemotherapy for the two groups of patients
Description
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)
Time Frame
2 years after inclusion
Title
Event-free survival of patients
Description
Time that passes before first appearance of Opportunistic Autoimmunity Secondary to cancer Immunotherapy. The baseline is the onset of cancer immunotherapy.
Time Frame
2 years after inclusion
Title
Description of flares or worsening of pre-existing autoimmune diseases
Description
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)
Time Frame
2 years after inclusion
Title
Comparison of baseline predictive factors of autoimmune manifestations for the two groups of patients
Description
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)
Time Frame
2 years after inclusion
Title
Changes in patients' quality of life over time and the impacts of OASI
Description
EQ-5D-5L general quality of life scores
Time Frame
2 years after inclusion
Title
Changes in patients' quality of life over time and the impacts of OASI
Description
EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire)
Time Frame
2 years after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacques-Eric GOTTENBERG, MD, PhD
Phone
03 88 12 79 53
Ext
0033
Email
jacques-eric.gottenberg@chru-strabourg.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques-Eric GOTTENBERG, MD, PhD
Organizational Affiliation
University Hospital, Strasbourg, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopitaux universitaires de strasbourg
City
Strasbourg
State/Province
Alsace
ZIP/Postal Code
67000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bertrand MENNECIER, MD
Phone
+33 3 69 55 09 05
Email
bertrand.mennecier@chru-strasbourg.fr

12. IPD Sharing Statement

Learn more about this trial

Patient-Reported AutoImmunity Secondary to Cancer immunothErapy

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