Immune-checkpoint inhibitor induced colitis
Conditions
Interventions
None listed
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients fom 18 years diagnosed with a malignancy - Indication for systemic ICI-treatment with nivolumab or pembrolizumab (anti-PD-1), atezolizumab, ipilimumab (anti-CTLA-4) monotherapy or the combination of nivolumab with ipilimumab. - WHO performance score 0-2
Exclusion criteria
Exclusion criteria: - Patients, who are not able to provide informed consent. - History of IBD - Life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence of any grade and grade 3/4 IMC within 12 weeks. 2. Development of grade 3 or 4 IMC with corresponding interval (start immune checkpoint inhibition until symptom onset). 3. Frequencies and phenotype of immune cell populations and cytokine production in the colon of patients prior to and during ICI treatment. 4. Differences in immune cell populations and cytokine production prior to and during ICI treatment, in patients who eventually develop grade 3 or 4 IMC as compared to those who do not develop IMC. | — |
Secondary
| Measure | Time frame |
|---|---|
| 5. Differences in the microbiome and metabolome prior to and during ICI treatment, in patients who eventually develop IMC as compared to those who do not develop IMC 6. Differences in circulating immune cell populations and cytokines prior to and during ICI treatment, in patients that eventually develop IMC as compared to those who do not develop IMC. 7. Differences in immune cell populations, cytokine production, microbiome and metabolome composition in patients undergoing different types of ICI-treatment (anti-PD-1/ anti-CTLA-4). 8. Transcriptome of intestinal tissue prior to and during ICI treatment | — |
Countries
Netherlands
Outcome results
None listed