Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06421116
Other study ID # 6378
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 7, 2024
Est. completion date December 31, 2025

Study information

Verified date February 2024
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Maria Antonietta D'Agostino, Professor
Phone +390630157807
Email mariaantoniettadagostino@policlinicogemelli.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Procedure:
Synovial ultrasound-guided biopsy Intestinal biopsy
Patients will undergo biopsies if needed for standard-of-care follow-up and after clinical indication.

Locations

Country Name City State
Italy Fondazione Policlinico Universitario A. Gemelli IRCCS Rome RM

Sponsors (1)

Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Other Invasion capacity assessment (synovial organoids) 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
Primary Viability assessment 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 Production of pro-inflammatory cytokines The production of cytokines in the culture supernatant of organoids will be evaluated using enzyme-linked immunosorbent assay (ELISA) 24 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04046913 - The ADDapt Diet in Reducing Crohn's Disease Inflammation N/A
Active, not recruiting NCT04989907 - A Study in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) Receiving Vedolizumab in Real-World Practice in Switzerland
Recruiting NCT05316584 - A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy N/A
Active, not recruiting NCT04990258 - A 24-month Real Life PErsistence Efficacy and Safety Study in IBD Patients in REMission Switched From Intravenous Infliximab to Subcutaneous Infliximab CT-P13 Remsima®SC
Completed NCT06216223 - Laser Versus Surgery in Anal Diseases in Inflammatory Bowel Patients N/A
Enrolling by invitation NCT06015789 - Self-care in Patients Affected by Inflammatory Bowel Disease and Caregivers' Contribution to Self-care
Recruiting NCT06065995 - StoMakker Mobile Application N/A
Recruiting NCT03282786 - Comparison of Carbon Dioxide (CO2) to Air Insufflation in Colonoscopy in Patients With Inflammatory Bowel Disease N/A
Recruiting NCT06002074 - SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases N/A
Recruiting NCT04960826 - Study of an Environmental Risk Factor in Crohn's Disease
Recruiting NCT05413941 - Internet-based Cognitive Behavioral Therapy in Inflammatory Bowel Disease N/A
Completed NCT03668249 - A Study to Characterize Multidimensional Model to Predict the Course of Crohn's Disease (CD)
Completed NCT00721812 - A First Time In Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 Phase 1
Recruiting NCT05809999 - IBD Neoplasia Surveillance RCT N/A
Recruiting NCT04138225 - The Ecological Role of Yeasts in the Human Gut
Recruiting NCT04991324 - Cholecalciferol Comedication in IBD - the 5C-study Phase 3
Completed NCT03173144 - Chronic Inflammatory Disease, Lifestyle and Treatment Response
Not yet recruiting NCT05043818 - A Clinical Study on the Screening of Intestinal Biomarkers in IBD Patients With Depression
Recruiting NCT03042091 - Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery Early Phase 1
Not yet recruiting NCT02858557 - The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases N/A