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

Inflammatory Bowel Diseases Clinical Trial

— ORGANOSPA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06421116
• Other study ID #: 6378
• Status: Recruiting
• Start date: March 7, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Maria Antonietta D'Agostino, Professor
• Phone: +390630157807
• Email: mariaantoniettadagostino[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• 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.

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Spondylarthritis
• Spondylitis
• Spondyloarthritis

Intervention

Procedure:
• Synovial ultrasound-guided biopsy Intestinal biopsy
Patients will undergo biopsies if needed for standard-of-care follow-up and after clinical indication.

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS	Rome	RM

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

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