Understanding how cancer treatments affect immune responses and side effects
Understanding and Anticipating Therapeutic Response And Immuno-meDIated Adverse Events in Anti-cancer Immune-checkpoint Inhibition: a Tissue Biopsy Based imaGing Study
This study looks at how cancer treatments that boost the immune system affect patients with advanced cancer, focusing on their immune responses and any side effects they might experience.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Brest Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Brest) |
| Trial ID | NCT05921123 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the immune response to anti-cancer immune checkpoint inhibitors (ICIs) and the associated immune-related adverse events (irAEs) in patients with advanced cancer. By analyzing tissue biopsies from patients treated with ICIs, the study seeks to identify specific immune cell populations and their roles in both therapeutic efficacy and toxicity. The research will focus on characterizing the tumor microenvironment and the immune infiltrate in tissues affected by irAEs, with the goal of establishing predictive factors for treatment response and adverse effects. This comprehensive approach may provide insights into optimizing cancer treatment strategies and managing side effects.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are receiving immune checkpoint inhibitors for advanced cancer and have sufficient archived tissue biopsies.
Not a fit: Patients who do not have advanced cancer or those who are not treated with immune checkpoint inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved predictions of treatment responses and better management of side effects for patients undergoing cancer immunotherapy.
How similar studies have performed: While the approach of characterizing immune responses in relation to cancer treatment is being explored, this specific study focuses on a novel combination of tissue analysis and immune checkpoint inhibitors, making it a unique investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Age ≥ 18 years old * Treated by Immune checkpoint inhibitor (ICI) for an advanced cancer * Treated at Brest University-Hospital, Morlaix Hospital, Quimper Hospital, Clinique Pasteur in Brest or Bordeaux University Hospital * With a tumor or tissue biopsy (organ target of irAEs) archived in sufficient quantity for Hyperion analysis * For the control group: patient with an inflammatory disease (autoimmune, autoinflammatory) who had a biopsy at diagnosis Exclusion Criteria: * Subject of guardianship (tutorship, curatorship) * Refusal to participate * Patient not meeting inclusion criteria for each point
Where this trial is running
Brest
- Brest University Hospital — Brest, France (Recruiting)
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.