Trials
Search / Trial NCT06421116

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

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · May 15, 2024

Trial Information

Current as of February 19, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to study spondyloarthritis, a type of arthritis that can also affect the gut. Researchers want to create tiny lab-made structures called "organoids" from the tissues of patients. These organoids will help them understand how the gut and joints influence each other in people with this condition. By comparing the organoids from patients with those from healthy individuals, the researchers hope to identify specific markers that could help in diagnosing or treating the disease.

To participate in this study, you need to be over 18 years old and able to give informed consent, which means you understand what the study involves and agree to join. If you have been diagnosed with spondyloarthritis and are scheduled for a biopsy of the gut or joint tissues, you may be eligible. However, if you have certain serious health issues, a history of specific cancers, or infections in the joint, you may not be able to participate. If you join the study, you can expect to provide tissue samples, which will be used to develop a better understanding of how spondyloarthritis affects the body.

Gender

ALL

Eligibility criteria

  • 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.

About Fondazione Policlinico Universitario Agostino Gemelli Irccs

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.

Locations

Rome, Rm, Italy

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0