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

May 15, 2024 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • RM
      • Rome, RM, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario A. Gemelli IRCCS
        • Contact:
        • Principal Investigator:
          • Maria Antonietta D'Agostino, Professor
        • Sub-Investigator:
          • Gerlando Natalello, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viability assessment
Time Frame: 24 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Production of pro-inflammatory cytokines
Time Frame: 24 months
The production of cytokines in the culture supernatant of organoids will be evaluated using enzyme-linked immunosorbent assay (ELISA)
24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Invasion capacity assessment (synovial organoids)
Time Frame: 24 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 9, 2024

First Submitted That Met QC Criteria

May 15, 2024

First Posted (Actual)

May 20, 2024

Study Record Updates

Last Update Posted (Actual)

May 20, 2024

Last Update Submitted That Met QC Criteria

May 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6378

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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