Synovial Tissue as a Biomarker in the Management of Pigmented Villonodular Synovitis (SYVIPRO)

March 26, 2026 updated by: Nantes University Hospital
Pigmented villonodular synovitis (PVNS) is a rare joint disease caused by the proliferation of synovial tissue, leading to significant pain and joint destruction. It typically begins between the ages of 30 and 50 and significantly affects patients' functionality. The proliferation is due to somatic mutations in some fibroblastic cells within the tissue, which triggers a massive recruitment of inflammatory cells. The condition is considered a benign tumor of the synovial membrane with a major inflammatory component. Diagnosing PVNS requires synovial tissue analysis, obtained either through surgical excision or guided needle biopsy. This biopsy technique, done as an outpatient procedure, is well tolerated and helps confirm the diagnosis before treatment. Our goal is to better understand this disease and determine if the analysis of synovial tissue could serve as a useful biomarker for patient management in the context of personalized medicine.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, multicentre, open-label study focusing on the collection and analysis of synovial tissue samples from PVNS patients. The study aims to explore the pathophysiology of PVNS and identify prognostic and predictive biomarkers.

Inclusion Criteria: Adults diagnosed with localized or diffuse PVNS, referred for therapeutic management.

Exclusion Criteria: Minors, pregnant or nursing women, individuals under guardianship, patients with severe thrombocytopenia, those on therapeutic anticoagulation, and patients declining participation.

Synovial tissue will be obtained either during surgical intervention (if indicated) or through guided needle biopsy. The biopsy is intended to be diagnostic and will also serve for research purposes. Samples will be analyzed using histological, immunohistochemically, and high-throughput methods.

Patients will be followed one year with two systematic visits (6 months and 1 year after the biopsy). At each visit, they will have a standardized clinical evaluation to assess pain, function and response to treatment. Thereafter, they will be followed as required by the clinical routine over a 4-year period, including clinical assessment and response to treatment.

The primary Outcome is the successful establishment of a patient cohort and synovial biocollection. The secondary Outcomes are the following: Tissue quality, biopsy tolerance, patient acceptability, and the effects of treatments on synovial explants.

Statistical Analysis: The study will include descriptive and predictive analyses, focusing on correlations between synovial abnormalities and clinical progression or treatment response.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

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 Locations

  • France
      • Lyon, France
      • Nantes, France
        • CHU de Nantes
        • Contact:
        • Principal Investigator:
          • Benoit LE GOFF
      • Paris, France
        • Hôpital Cochin APHP
        • Principal Investigator:
          • Jérome AVOUAC
        • Contact:

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

No

Description

Inclusion Criteria:

  • Patient >18 years
  • Diagnosis of localized or diffuse villonodular synovitis
  • Referred for therapeutic management
  • Affiliated with or benefiting from a social security scheme

Exclusion Criteria:

  • Minors
  • Pregnant women
  • Nursing mothers
  • Protected patients: patients under guardianship or curatorship, safeguard of justice
  • Patients deprived of liberty
  • Curative anticoagulation
  • Thrombocytopenia < 50,000 platelets/mm3

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Synovial sampling
Synovial sampling on first visit
Procedure: synovial biopsy

Synovial samples are taken either :

  • immediately after surgery
  • during an ultrasound-guided synovial biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of samples
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tissue quality
Time Frame: 1 month
assessed using Krenn's histological score
1 month
number of adverse events
Time Frame: 1 year
1 year
Patient acceptability
Time Frame: 1 day
using a visual analogue scale
1 day
Cluster analysis of results from high-throughput experiments
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Nantes University Hospital

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 (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

April 1, 2030

Study Registration Dates

First Submitted

March 17, 2026

First Submitted That Met QC Criteria

March 26, 2026

First Posted (Actual)

March 31, 2026

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC24_0068

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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