Patient-Reported AutoImmunity Secondary to Cancer immunothErapy

  • STATUS
    Recruiting
  • End date
    Nov 24, 2026
  • participants needed
    2000
  • sponsor
    University Hospital, Strasbourg, France
Updated on 24 January 2021

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.

Details
Condition Opportunistic Autoimmune Diseases
Treatment Biological collection
Clinical Study IdentifierNCT03849131
SponsorUniversity Hospital, Strasbourg, France
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Opportunistic Autoimmune Diseases?
Do you have any of these conditions: Do you have Opportunistic Autoimmune Diseases??
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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