Validation of a Preclinical Model Based on Patient-derived Organoids for the Study of the Gut-joint Axis in Spondyloarthritis

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 site in 1 country60 target enrollmentMarch 7, 2024

ConditionsSpondyloarthritis Inflammatory Bowel Diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Spondyloarthritis
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Enrollment: 60
Locations: 1
Primary Endpoint: Viability assessment
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

March 7, 2024

End Date

December 31, 2025

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Viability assessment

Time Frame: 24 months

The viability of organoids will be determined using an adenosine triphosphate (ATP) detection assay based on luminescence using a commercially available luciferase.