NCT05813418 Identification of Predictive Biomarkers for Immune-Related Adverse Events (irAEs) in Patients Undergoing Immune CheckPoint Inhibitors (ICPI) Treatment
| NCT ID | NCT05813418 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire, Amiens |
| Condition | Immunotherapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2021-07-02 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2021-07-02 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * patient with cancer, whatever initial tumoral histology and disease stage under ICPI treatment (anti-PD1 and/or anti-CTLA-4) * age \> 18 * followed in oncology, pneumology, dermatology, gastroenterology departments of Amiens-Picardie University Hospital or Saint Quentin hospital * who received verbal and written information, and signed the consent form for the study Exclusion Criteria: * non ICPI treated patients * patient who received a first line of ICPI treatment * patient who received or is receiving MEK inhibitors as a treatment (because of possible lower response to ICPI treatment when associated)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05813418 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Immunotherapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05813418 currently recruiting?
Yes, NCT05813418 is actively recruiting participants. Contact the research team at bourdenet.gwladys@chu-amiens.fr for enrollment information.
Where is the NCT05813418 trial being conducted?
This trial is being conducted at Amiens, France.
Who is sponsoring the NCT05813418 clinical trial?
NCT05813418 is sponsored by Centre Hospitalier Universitaire, Amiens. The trial plans to enroll 150 participants.