An interventional study of synovial biopsy in Synovitis Villonodular, sponsored by Nantes University Hospital. Recruiting at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Nantes University Hospital · Not applicable, Interventional, and Other
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.
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.
20 studies on the registry are indexed under Synovitis, Pigmented Villonodular; 2 are open to participants now.
This study's planned enrollment of 30 is below the median of 36 across 17 interventional studies indexed under Synovitis, Pigmented Villonodular.
Browse Synovitis, Pigmented Villonodular studies →Nantes University Hospital is the lead sponsor of 839 studies on the registry; 195 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Synovial sampling on first visit
Procedure: synovial biopsy
Synovial samples are taken either : * immediately after surgery * during an ultrasound-guided synovial biopsy
number of samples
Time frame: 1 day
Tissue quality
assessed using Krenn's histological score
Time frame: 1 month
number of adverse events
Time frame: 1 year
Patient acceptability
using a visual analogue scale
Time frame: 1 day
Cluster analysis of results from high-throughput experiments
Time frame: 1 year
Started Oct 2026 (actual). Primary completion is estimated for Oct 2030, 48 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 6, 2026: start Sep 2026 → Oct 2026, primary completion Sep 2030 → Oct 2030 and completion Sep 2030 → Oct 2030.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Synovitis, Pigmented Villonodular →