- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06421116
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
- Name: Maria Antonietta D'Agostino, Professor
- Phone Number: +390630157807
- Email: mariaantoniettadagostino@policlinicogemelli.it
Study Contact Backup
- Name: Gerlando Natalello, Dr
- Phone Number: +390630157807
- Email: gerlando.natalello1@guest.policlinicogemelli.it
Study Locations
-
-
RM
-
Rome, RM, Italy, 00168
- Recruiting
- Fondazione Policlinico Universitario A. Gemelli IRCCS
-
Contact:
- Maria Antonietta D'Agostino, Professor
- Phone Number: +390630157807
- Email: mariaantoniettadagostino@policlinicogemelli.it
-
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.
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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