Patient-Reported AutoImmunity Secondary to Cancer immunothErapy (PRAISE)
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ClinicalTrials.gov Identifier: NCT03849131 |
Recruitment Status :
Recruiting
First Posted : February 21, 2019
Last Update Posted : August 18, 2022
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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 Type : | Interventional (Clinical Trial) |
Estimated 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 : | November 29, 2019 |
Estimated Primary Completion Date : | November 2025 |
Estimated Study Completion Date : | November 2025 |

- 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
- 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
- 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)
- 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)
- 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)
- 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)
- 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)
- 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.
- 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)
- 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)
- 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
- 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)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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.
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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

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
Contact: Jacques-Eric GOTTENBERG, MD, PhD | 03 88 12 79 53 ext 0033 | jacques-eric.gottenberg@chru-strabourg.fr |
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 |
Principal Investigator: | Jacques-Eric GOTTENBERG, MD, PhD | University Hospital, Strasbourg, France |
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: | August 18, 2022 |
Last Verified: | August 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
monoclonal anti-PD-1 immunotherapy monoclonal anti-CTLA-4 immunotherapy checkpoint inhibitors |
autoimmune manifestations patient reported outcome oncology |
Autoimmune Diseases Immune System Diseases |