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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-07

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Spondyloarthritis Inflammatory Bowel Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Synovial ultrasound-guided biopsy Intestinal biopsy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No