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NCT Number: NCT07503821

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

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.

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Key information

Conditions

Synovitis Villonodular Giant Cell Tumor of Tendon Sheath Giant Cell Tumors Joint Diseases Muscular Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Synovitis Synovitis, Pigmented Villonodular Tendinopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon, Lyon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

synovial biopsy

Procedure

Synovial samples are taken either :

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

Primary outcomes

  1. number of samples

    Time frame: 1 day

Secondary outcomes

  1. Tissue quality

    Time frame: 1 month

    assessed using Krenn's histological score

  2. number of adverse events

    Time frame: 1 year

  3. Patient acceptability

    Time frame: 1 day

    using a visual analogue scale

  4. Cluster analysis of results from high-throughput experiments

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Benoit Le Goff, PU-PH

CONTACT

[email protected]

02 40 08 48 25

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: SYVIPRO

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Mar 31, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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