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Clinical Trials/NCT06737952
NCT06737952Not yet recruitingNot Applicable

Cellular and Molecular Analysis of Synovial Tissue of Patients With Arthritis

University Hospital, Basel, Switzerland0 sites90 target enrollmentStarted: May 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
90
Primary Endpoint
Grade of synovitis

Study Overview

Brief Summary

This study aims to study the inflammatory response in various forms of arthritis.

Detailed Description

Arthritis, a significant heald burden is characterized by joint inflammation that severely impacts patients' quality of live. Despite advancements in treatment, many individuals with conditions like rheumatoid arthritis (RA), osteoarthritis (OA), and spondyloarthritis (SpA) do not achieve satisfactory outcomes, underscoring the need for more precise therapeutic strategies.

The project aims to characterize the inflammatory response in various form of arthritis by collecting and analyzing synovial tissue-the connective tissue lining joints. Biopsies will be collected through ultrasound-guided biopsies (UGSB), a minimally invasive and well-tolerated procedure. Presence of immune and stromal cells in the tissue, their interactions, and their relationship to clinical symptoms are characterized by histological and molecular methods. By comparing these features across different forms of arthritis, the study aims to identify molecular pathways and biomarkers that distinguish these diseases and their subtypes. The study hopes to contribute to a broader understanding of arthritis pathophysiology, ultimately translating into novel therapeutic targets and tailored clinical strategies.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age >18 years
  • Clinically relevant arthritis in one or more joints as assessed by the treating rheumatologist, including RA, SpA, connective tissue disease and OA.

Exclusion Criteria

  • Known allergies to local anesthetics
  • Family history of bleeding, history of increased bleeding tendency or prolonged bleeding, current treatment with oral anticoagulants or platelet aggregation inhibitors; Quick < 65%, international normalised ratio (INR) ≥ 1.3, thrombocyte count < 100'000/μl, activated partial thromboplastin time (aPTT) > 37 sec
  • Inability or insufficient knowledge of project language to understand the information given in the informed consent form

Outcomes

Primary Outcomes

Grade of synovitis

Time Frame: immediately after collection to study completion, up to 5 years

assessed by the Krenn score in the hematoxylin and eosin staining (Score 0-3, 0=normal, 3=severe)

classification pathotypes

Time Frame: immediately after collection to study completion, up to 5 years

immunohistochemical staining with cell type specific markers including CD15, CD68, CD3, CD20, CD138 of the collected tissues from different arthritis subtypes

comparing transcriptomic signature

Time Frame: immediately after collection to study completion, up to 5 years

single-cell RNA sequencing of collected tissues from different arthritis subtypes to identify disease specific biomarkers.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University Hospital, Basel, Switzerland
Sponsor Class
Other
Responsible Party
Sponsor

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