Opportunistic Autoimmune DiseasesPhase 4PRAISENCT03849131
Patient-Reported AutoImmunity Secondary to Cancer immunothErapy
A Phase 4 study testing Biological collection in people with Opportunistic Autoimmune Diseases, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opportunistic Autoimmune Diseases
- What is being tested?
- Biological collection
- How many people
- 905 participants
- Where
- 1 siteFrance
- Study dates
- 29 Nov 2019to Jun 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Opportunistic Autoimmune Diseases
- Being tested
- Biological collection
- Keywords
- monoclonal anti-PD-1 immunotherapy, monoclonal anti-CTLA-4 immunotherapy, checkpoint inhibitors, autoimmune manifestations, patient reported outcome, oncology
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological collectionBiological
Also called Biobank
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years after inclusion
Secondary outcomes (10)
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)
Measured: 2 years after inclusion
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)
Measured: 2 years after inclusion
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)
Measured: 2 years after inclusion
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)
Measured: 2 years after inclusion
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)
Measured: 2 years after inclusion
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.
Measured: 2 years after inclusion
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)
Measured: 2 years after inclusion
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)
Measured: 2 years after inclusion
Changes in patients' quality of life over time and the impacts of OASI
EQ-5D-5L general quality of life scores
Measured: 2 years after inclusion
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)
Measured: 2 years after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start29 Nov 2019
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opportunistic Autoimmune DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 905 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques-Eric GOTTENBERG, MD, PhD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849131
- Sponsor's protocol ID
- 6994
- Acronym
- PRAISE
- Status last verified
- Mar 2025
- First submitted
- 9 Jan 2019
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Reported AutoImmunity Secondary to Cancer immunothErapy
- ClinicalTrials.gov ID
- NCT03849131
- Acronym / sponsor ID
- PRAISE / 6994
- Conditions
- Opportunistic Autoimmune Diseases
- Keywords
- monoclonal anti-PD-1 immunotherapy, monoclonal anti-CTLA-4 immunotherapy, checkpoint inhibitors, autoimmune manifestations, patient reported outcome, oncology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 905 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 29 Nov 2019 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 21 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological collectionAlso: BiobankBlood 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 | Biological | – |
Primary outcome
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
10 secondary outcomes
Comparison of the age for the two groups of patients
Time frame: 2 years after inclusion
Comparison of the gender for the two groups of patients
Time frame: 2 years after inclusion
Comparison of the body-mass index for the two groups of patients
Time frame: 2 years after inclusion
Comparison of the types of cancer 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
Time frame: 2 years after inclusion
Event-free survival of patients
Time frame: 2 years after inclusion
Description of flares or worsening of pre-existing autoimmune diseases
Time frame: 2 years after inclusion
Comparison of baseline predictive factors of autoimmune manifestations for the two groups of patients
Time frame: 2 years after inclusion
Changes in patients' quality of life over time and the impacts of OASI
Time frame: 2 years after inclusion
Changes in patients' quality of life over time and the impacts of OASI
Time frame: 2 years after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques-Eric GOTTENBERG, MD, PhD principal investigator
University Hospital, Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Biological collection in people with Opportunistic Autoimmune Diseases, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of severe autoimmune manifestations in patients treated with BMS checkpoint inhibitors. (time frame: 2 years after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.