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

NCT06421116 | Recruiting

• 1 other identifier: 6378
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Spondyloarthritis; Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Production of pro-inflammatory cytokines

  24 months

Other Outcomes (1)

• Invasion capacity assessment (synovial organoids)

  24 months

Interventions

Synovial ultrasound-guided biopsy Intestinal biopsy PROCEDURE

Patients will undergo biopsies if needed for standard-of-care follow-up and after clinical indication.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected by Spondyloarthtitis. Controls with inflammatory or non-inflammatory conditions.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, RM, 00168, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Synovial biopses and intestinal biopses

MeSH Terms

Conditions

Spondylarthritis; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Maria Antonietta D'Agostino, Professor

CONTACT

+390630157807; mariaantoniettadagostino@policlinicogemelli.it

Gerlando Natalello, Dr

CONTACT

+390630157807; gerlando.natalello1@guest.policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: May 20, 2024
• Study Start: March 7, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: May 20, 2024

Record last verified: 2024-02

Locations

IT (1)