Validation of a patient-derived organoid model for studying gut and joint health in spondyloarthritis
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 IRCCS · NCT06421116
This study is testing a new way to grow tiny models of gut and joint tissues from people with spondyloarthritis to see how they work together and find important markers for the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other) |
| Locations | 1 site (Rome, RM) |
| Trial ID | NCT06421116 on ClinicalTrials.gov |
What this trial studies
This project focuses on developing and validating a model of human organoids derived from patients with spondyloarthritis, specifically examining synovial and intestinal tissues to understand the gut-joint axis. The study will analyze the tissue marker profiles of these patient-derived organoids through gene expression, immunohistochemistry, and cytokine production, comparing them with control samples to identify specific biomarkers. The approach involves obtaining biopsies from both the intestine and synovial tissues to create a comprehensive understanding of the disease mechanisms.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with a clinical indication for intestinal and/or synovial biopsy who meet the ASAS classification criteria for spondyloarthritis.
Not a fit: Patients with actively treated cancer or severe comorbidities that may compromise sample quality are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the identification of novel biomarkers for spondyloarthritis, improving diagnosis and treatment strategies for patients.
How similar studies have performed: While the specific approach of using patient-derived organoids in this context is relatively novel, similar studies have shown promise in other areas of research.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rome, RM
- Fondazione Policlinico Universitario A. Gemelli IRCCS — Rome, RM, Italy (RECRUITING)
Study contacts
- Study coordinator: Maria Antonietta D'Agostino, Professor
- Email: mariaantoniettadagostino@policlinicogemelli.it
- Phone: +390630157807
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Spondyloarthritis, Inflammatory Bowel Diseases