Actively Recruiting
A Clinical and Biological Prospective Database of Patients Treated With Anticancer Immunotherapy and Follow up of Their Immune-related Adverse Events irAE
Led by Hospices Civils de Lyon · Updated on 2021-07-27
2000
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are collecting detailed clinical and biological information from patients starting anticancer immunotherapy to better understand immune-related side effects that can affect various organs. The study aims to identify factors that increase the risk of these toxicities and to develop ways to prevent or manage them effectively. This observational study will help personalize future immunotherapy treatments by balancing benefits and risks for each patient. Participants receive immunotherapy drugs such as checkpoint inhibitors including PD-1, PD-L1, CTLA4, and others either alone or with other cancer treatments. Patients are enrolled before their first immunotherapy treatment and followed for up to 5 years or until they stop treatment permanently. The study also collects blood, plasma, serum, and immune cells samples before, during, and at the onset of immune-related side effects. During the study, participants will be regularly monitored through clinical evaluations and biological sample collections to track any immune-related toxicities. Researchers will estimate the incidence of these side effects over 10 years. Data collected will include clinical details and biological markers to support further research on mechanisms causing toxicity. This long-term follow-up helps improve understanding of immunotherapy safety and guides future patient care.
CONDITIONS
Brief Title
A Clinical and Biological Prospective Database of Patients Treated With Anticancer Immunotherapy and Follow up of Their Immune-related Adverse Events irAE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years
- Starting anticancer immunotherapy treatment (immune checkpoint inhibitors like anti-PD-1, anti-PD-L1, anti-CTLA4, anti-Lag-3, anti-Tim-3, anti-TIGIT, or other new immunotherapy) alone or with other cancer drugs
- Previous immunotherapy allowed if last treatment was more than 6 months ago
- Received written information about the study
- Receiving immunotherapy as part of a clinical trial allowed if permitted by that trial's sponsor
- Participation allowed if in a clinical trial with blinded treatment not involving immunotherapy and if that trial allows participation in non-interventional studies
- Patients who stopped the study due to treatment change can rejoin if new immunotherapy starts after 6 months from previous one
- Signed informed consent for biological sample collection
You will not qualify if you...
- Received immunotherapy within 6 months before joining the study
- Under 18 years old
- Pregnant women
- Under legal protection
- Refusal to participate
- Weight 50 kg or less for biological collection
- Hemoglobin less than 90 g/L at inclusion
- Participating in clinical trials with blood samples taken for other ancillary studies
Research Team
J
Jonathan LOPEZ, MD
S
Sara CALATTINI, PhD
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