Patient-Reported AutoImmunity Secondary to Cancer immunothErapy
NCT ID: NCT03849131
Last Updated: 2025-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
905 participants
INTERVENTIONAL
2019-11-29
2025-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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University Hospital, Strasbourg, France
OTHER
Responsible Party
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Principal Investigators
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Jacques-Eric GOTTENBERG, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Strasbourg, France
Locations
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Hopitaux universitaires de strasbourg
Strasbourg, Alsace, France
Countries
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Other Identifiers
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6994
Identifier Type: -
Identifier Source: org_study_id
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