Patient-Reported AutoImmunity Secondary to Cancer immunothErapy

NCT03849131 | Active Not Recruiting Phase 4

• 1 other identifier: 6994
• Study Type: interventional
• Target: 905
• Locations: 1 country
• Sites: 1

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.

Conditions

Opportunistic Autoimmune Diseases

Keywords

monoclonal anti-PD-1 immunotherapy; monoclonal anti-CTLA-4 immunotherapy; checkpoint inhibitors; autoimmune manifestations; patient reported outcome; oncology

Outcome Measures

Primary Outcomes (1)

• 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

  2 years after inclusion

Secondary Outcomes (10)

• Comparison of the age for the two groups of patients

  2 years after inclusion

• Comparison of the gender for the two groups of patients

  2 years after inclusion

• Comparison of the body-mass index for the two groups of patients

  2 years after inclusion

• Comparison of the types of cancer for the two groups of patients

  2 years after inclusion

• Comparison of the number of previous lines of chemotherapy for the two groups of patients

  2 years after inclusion

Interventions

Biological collection BIOLOGICAL

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

Also known as: Biobank

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hopitaux universitaires de strasbourg

Strasbourg, Alsace, 67000, France

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Biological Specimen Banks

Intervention Hierarchy (Ancestors)

Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Jacques-Eric GOTTENBERG, MD, PhD

  University Hospital, Strasbourg, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: February 21, 2019
• Study Start: November 29, 2019
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

FR (1)