Inflammatory Bowel Diseases Clinical Trial
— ORGANOSPAOfficial title:
Validation of a Preclinical Model Based on Patient-derived Organoids for the Study of the Gut-joint Axis in Spondyloarthritis
NCT number | NCT06421116 |
Other study ID # | 6378 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 7, 2024 |
Est. completion date | December 31, 2025 |
This project aims to develop and validate a model of human organoids derived from patients with Spondyloarthritis, focusing on synovial and intestinal tissues as targets of the gut-joint axis. The tissue marker profile of patient-derived organoids studied by gene expression, immunohistochemistry, and cytokine production profile will be compared with that of controls in order to test for the presence of specific biomarkers.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - More than 18 years of age; - Ability to understand and sign an informed consent form; - Clinical indication for intestinal and/or synovial biopsy; - Only for SpA patients group: meeting ASAS classification criteria. Exclusion Criteria: - Actively treated cancer; - Severe comorbidities that, in the investigator's opinion, may affect the quality of samples for planned experimental applications; - Only for patients undergoing ileal-colic biopsy: history of colorectal cancer disease, celiac disease; - Only for patients undergoing a synovial biopsy: septic arthritis. |
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione Policlinico Universitario A. Gemelli IRCCS | Rome | RM |
Lead Sponsor | Collaborator |
---|---|
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Invasion capacity assessment (synovial organoids) | Fibroblast-like synoviocytes (FLS) will be dispensed into a well of a Fluorobook invasion plate. The fluorescence will be measured as an index of FLS invasion capacity in the presence of a basement membrane extract. | 24 months | |
Primary | Viability assessment | The viability of organoids will be determined using an adenosine triphosphate (ATP) detection assay based on luminescence using a commercially available luciferase. | 24 months | |
Secondary | Production of pro-inflammatory cytokines | The production of cytokines in the culture supernatant of organoids will be evaluated using enzyme-linked immunosorbent assay (ELISA) | 24 months |
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