Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT06414304
Eligibility Criteria:
Inclusion Criteria:
* Male/female participants must be at least 18 years of age on the day of signing informed consent and have a histologically confirmed diagnosis of colorectal cancer.
* Verified MSI/dMMR positivity as measured by 5-loci PCR or 4-antibody IHC.
* The patient is scheduled to start treatment with any of the immune checkpoint inhibitors 2-4 weeks after the inclusion in the study.
* Have provided an archival tumor tissue sample obtained prior to the start of treatment with immune checkpoint inhibitor(s). Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides.
* Patient has to be able to provide serial blood samples during the course of treatment, as well as on every follow-up tumor scan.
* The participant (or legally acceptable representative if applicable) provides written informed consent to participate in the trial.
* Have measurable disease based on RECIST 1.1.
* Have adequate organ function.
Exclusion Criteria:
* Prior treatment with immune checkpoint inhibitors.
* For female participants: pregnancy or planned pregnancy.
* The unavailability of the tumor or serial liquid biopsy samples.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06414304
Study Brief:
Protocol Section:
NCT06414304