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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Spondyloarthritis; Inflammatory Bowel Diseases

Treatments: Procedure: Synovial ultrasound-guided biopsy Intestinal biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT06421116

6378

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.