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Patient-Reported AutoImmunity Secondary to Cancer immunothErapy (PRAISE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03849131
Recruitment Status : Recruiting
First Posted : February 21, 2019
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Study Description
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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
Opportunistic Autoimmune Diseases Biological: Biological collection Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 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 : November 29, 2019
Estimated Primary Completion Date : November 2026
Estimated Study Completion Date : November 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Biological: Biological collection

    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 Name: Biobank

Outcome Measures
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Primary Outcome Measures :
  1. incidence of severe autoimmune manifestations in patients treated with BMS checkpoint inhibitors. [ Time Frame: 5 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 [ Time Frame: 5 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: 5 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: 5 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: 5 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: 5 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: 5 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: 5 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: 5 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03849131


Contacts
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Contact: Jacques-Eric GOTTENBERG, MD, PhD 03 88 12 79 53 ext 0033 jacques-eric.gottenberg@chru-strabourg.fr

Locations
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France
Hopitaux universitaires de strasbourg Recruiting
Strasbourg, Alsace, France, 67000
Contact: Bertrand MENNECIER, MD    +33 3 69 55 09 05    bertrand.mennecier@chru-strasbourg.fr   
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Principal Investigator: Jacques-Eric GOTTENBERG, MD, PhD University Hospital, Strasbourg, France
More Information
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03849131    
Other Study ID Numbers: 6994
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020

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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:
monoclonal anti-PD-1 immunotherapy
monoclonal anti-CTLA-4 immunotherapy
checkpoint inhibitors
 autoimmune manifestations
patient reported outcome
oncology
Additional relevant MeSH terms:
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Autoimmune Diseases
Immune System Diseases