Identifying biomarkers for immune-related side effects in cancer patients receiving immunotherapy
Identification of Predictive Biomarkers for Immune-Related Adverse Events (irAEs) in Patients
NA · Centre Hospitalier Universitaire, Amiens · NCT05813418
This study is trying to find out if certain blood markers can help predict which cancer patients receiving immunotherapy are more likely to experience serious side effects.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Amiens, Picardie) |
| Trial ID | NCT05813418 on ClinicalTrials.gov |
What this trial studies
This study aims to identify predictive biomarkers for immune-related adverse events (irAEs) in patients undergoing treatment with immune checkpoint inhibitors (ICPI). By analyzing blood samples from cancer patients treated with ICPI, the research seeks to determine which individuals are at higher risk for developing severe immune toxicities. The findings could help tailor treatment plans and improve patient safety by identifying those who may need closer monitoring or alternative therapies. The study is conducted at the Amiens-Picardie University Hospital and Saint Quentin Hospital.
Who should consider this trial
Good fit: Ideal candidates include adult cancer patients over 18 years old who are currently receiving immune checkpoint inhibitors.
Not a fit: Patients who are not receiving immune checkpoint inhibitors or those who have previously been treated with MEK inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better management of immunotherapy side effects, enhancing patient safety and treatment outcomes.
How similar studies have performed: Other studies have shown promise in identifying biomarkers for adverse events in immunotherapy, suggesting that this approach could yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Amiens, Picardie
- CHU Amiens Picardie — Amiens, Picardie, France (RECRUITING)
Study contacts
- Study coordinator: Gwladys BOURDENET, DR
- Email: bourdenet.gwladys@chu-amiens.fr
- Phone: 03.22.08.70.72
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Immunotherapy, Immune Checkpoint Inhibitors, Immune-related Adverse Event, Predictive Biomarkers, immunotherapy, immune checkpoint inhibitors, predictive biomarkers, plasmatic cytokines