Clinical trial NCT03849131: Patient-Reported AutoImmunity Secondary to Cancer immunothErapy
Official title: Patient-Reported AutoImmunity Secondary to Cancer immunothErapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Opportunistic Autoimmune Diseases
Keywords: monoclonal anti-PD-1 immunotherapy
monoclonal anti-CTLA-4 immunotherapy
checkpoint inhibitors
autoimmune manifestations
patient reported outcome
oncology
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-02-21
Enrollment: 905
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: incidence of severe autoimmune manifestations in patients treated with BMS checkpoint inhibitors.
timeFrame: 2 years after inclusion
Secondary outcomes:
measure: Comparison of the age for the two groups of patients
timeFrame: 2 years after inclusion
measure: Comparison of the gender for the two groups of patients
timeFrame: 2 years after inclusion
measure: Comparison of the body-mass index for the two groups of patients
timeFrame: 2 years after inclusion
measure: Comparison of the types of cancer for the two groups of patients
timeFrame: 2 years after inclusion
measure: Comparison of the number of previous lines of chemotherapy for the two groups of patients
timeFrame: 2 years after inclusion
measure: Event-free survival of patients
timeFrame: 2 years after inclusion
measure: Description of flares or worsening of pre-existing autoimmune diseases
timeFrame: 2 years after inclusion
measure: Comparison of baseline predictive factors of autoimmune manifestations for the two groups of patients
timeFrame: 2 years after inclusion
measure: Changes in patients' quality of life over time and the impacts of OASI
timeFrame: 2 years after inclusion
measure: Changes in patients' quality of life over time and the impacts of OASI
timeFrame: 2 years after inclusion
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hopitaux universitaires de strasbourg
state: Alsace
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Jacques-Eric GOTTENBERG, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: