Actively Recruiting
Identification of Predictive Biomarkers for Immune-Related Adverse Events in Patients Receiving Immune Checkpoint Inhibitor Treatment
Led by Centre Hospitalier Universitaire, Amiens · Updated on 2025-06-04
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Centre Hospitalier Universitaire, Amiens
Lead Sponsor
C
Central Hospital Saint Quentin
Collaborating Sponsor
AI-Summary
What this Trial Is About
Cancer treatment has evolved from surgery, radiotherapy, and chemotherapy to include targeted therapies like tyrosine kinase inhibitors and immune checkpoint inhibitors (ICPI), such as anti-CTLA-4 and anti-PD1. These ICPIs activate the immune system to fight tumors and can produce lasting responses, even with metastases. However, ICPIs may cause serious immune-related side effects called irAEs, including colitis, hepatitis, dermatitis, and thyroiditis, which can lead to treatment discontinuation or severe health issues. Detecting patients at risk for irAEs is important due to the growing use of ICPIs and their long-term effects. This study involves collecting blood samples to measure cytokine concentrations, including IL6, IL10, IL15, IL8, INFgamma, MCP-1, MIP 1 alpha, MIP 1 beta, sIL2R, and sIL6R, over a 6-month period. These measurements aim to identify biomarkers that predict immune-related adverse events in patients receiving ICPI treatment. The study includes patients undergoing anti-PD1 and/or anti-CTLA-4 therapies in oncology, pneumology, dermatology, or gastroenterology departments. Participants will provide blood samples to monitor changes in specific cytokine levels from baseline during the study. Researchers will evaluate these variations to understand their association with irAEs. The study tracks these outcomes over six months, assessing immune markers to improve detection of patients at risk. The total participation involves follow-up and monitoring through blood collection at set intervals to gather data on immune responses and adverse events.
CONDITIONS
Brief Title
Identification of Predictive Biomarkers for Immune-Related Adverse Events (irAEs) in Patients Undergoing Immune CheckPoint Inhibitors (ICPI) Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with cancer, any tumor type and disease stage, currently receiving immune checkpoint inhibitor treatment (anti-PD1 and/or anti-CTLA-4)
- Age 18 years or older
- Followed in oncology, pneumology, dermatology, or gastroenterology departments of Amiens-Picardie University Hospital or Saint Quentin hospital
- Received verbal and written information about the study and signed the consent form
You will not qualify if you...
- Not currently treated with immune checkpoint inhibitors
- Received a first line of immune checkpoint inhibitor treatment
- Receiving or previously received MEK inhibitors as treatment due to possible lower response to immune checkpoint inhibitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants undergo blood retrievals for cytokine concentration measurements during their ongoing immune checkpoint inhibitor treatment.
Periodic visits for blood collection during treatment
Trial Site Locations
Total: 1 location
1
CHU Amiens Picardie
Amiens, Picardie, France, 80054
Actively Recruiting
Research Team
G
Gwladys BOURDENET, DR
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
0
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