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

Recruiting

• Conditions: Spondyloarthritis; Inflammatory Bowel Diseases

• Registration Number: NCT06421116
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-09
• Study Start: 2024-03-07
• Study First Submitted QC: 2024-05-15
• Last Update Submitted: 2024-05-15
• Study First Posted: 2024-05-20
• Last Update Posted: 2024-05-20
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Viability assessment	24 months	The viability of organoids will be determined using an adenosine triphosphate (ATP) detection assay based on luminescence using a commercially available luciferase.

Secondary Outcome Measures

Name	Time	Method
Production of pro-inflammatory cytokines	24 months	The production of cytokines in the culture supernatant of organoids will be evaluated using enzyme-linked immunosorbent assay (ELISA)

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS; 🇮🇹 Rome, RM, Italy