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

RECRUITINGSponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Actively Recruiting
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
Started2024-03-07
Est. completion2024-12-31
Eligibility
Age18 Years+
View on ClinicalTrials.gov →

NCT06421116

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.

Eligibility

Age: 18 Years+
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.

Conditions3

ArthritisInflammatory Bowel DiseasesSpondyloarthritis

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