Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05813418

Identification of Predictive Biomarkers for Immune-Related Adverse Events (irAEs) in Patients Undergoing Immune CheckPoint Inhibitors (ICPI) Treatment

Led by Centre Hospitalier Universitaire, Amiens · Updated on 2025-06-04

150

Participants Needed

1

Research Sites

230 weeks

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

In the last decades, cancer treatment was based on surgery, radiotherapy and chemotherapy. Recently, treatments have largely evolved, first with targeted therapies (notably tyrosin kinase inhibitors, TKI) and then with immune checkpoint inhibitors (ICPI, notably anti-CTLA-4 and anti- PD1). The last ones can induce durable anti-tumoral responses in patients, even if metastases are present. Their mechanisms of action are focused on the activation of immune system in order to eliminate the tumor. ICPI, because of their mechanisms of action, target immune tolerance key components and can induce important immune toxicities (colitis, hepatitis, dermatitis, thyroiditis ...), leading to early discontinuation of treatment, severe or chronic morbidity, and can sometimes be lethal. It is of importance to detect patient at risk of irAEs, because of the increasing use of ICPI and the long- term response capacity in treated patients.

CONDITIONS

Official Title

Identification of Predictive Biomarkers for Immune-Related Adverse Events (irAEs) in Patients Undergoing Immune CheckPoint Inhibitors (ICPI) Treatment

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient with cancer, any tumor type and disease stage, currently under immune checkpoint inhibitor treatment (anti-PD1 and/or anti-CTLA-4)
  • Age over 18 years
  • Receiving care in oncology, pneumology, dermatology, or gastroenterology departments of Amiens-Picardie University Hospital or Saint Quentin hospital
  • Provided verbal and written information and signed consent form for the study
Not Eligible

You will not qualify if you...

  • Not receiving immune checkpoint inhibitor treatment
  • Received a first line of immune checkpoint inhibitor treatment
  • Currently receiving or previously received MEK inhibitors as treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CHU Amiens Picardie

Amiens, Picardie, France, 80054

Actively Recruiting

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Research Team

G

Gwladys BOURDENET, DR

CONTACT

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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Identification of Predictive Biomarkers for Immune-Related Adverse Events (irAEs) in Patients Undergoing Immune CheckPoint Inhibitors (ICPI) Treatment | DecenTrialz