Synovitis VillonodularSYVIPRONCT07503821
Synovial Tissue as a Biomarker in the Management of Pigmented Villonodular Synovitis
A study testing synovial biopsy in people with Synovitis Villonodular, run by Nantes University Hospital at 3 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Synovitis Villonodular
- What is being tested?
- synovial biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesFrance
- Study dates
- 30 Oct 2026to 30 Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient >18 years
- Diagnosis of localized or diffuse villonodular synovitis
- Referred for therapeutic management
- Affiliated with or benefiting from a social security scheme
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Not yet recruiting
Hospices Civils de Lyon
Lyon
Fabienne COURY, 08 25 08 25 69, fabienne.coury-lucas@chu-lyon.fr
Fabienne COURY
- Recruiting
CHU de Nantes
Nantes
Benoît LE GOFF, 0240084825, benoit.legoff@chu-nantes.fr
Benoit LE GOFF
- Not yet recruiting
Hôpital Cochin APHP
Paris
Jérome AVOUAC, 01 58 41 25 87, jerome.avouac@cch.aphp.fr
Jérome AVOUAC
About this study
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.
Read the 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.
- Conditions
- Synovitis Villonodular
- Being tested
- synovial biopsy
- Medical subject headings
- Synovitis, Pigmented Villonodular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
synovial biopsyProcedure or surgery
Synovial samples are taken either :
- immediately after surgery
- during an ultrasound-guided synovial biopsy
| Study group | Role | What they receive |
|---|---|---|
| Synovial sampling | Experimental | Synovial sampling on first visit Receives: Procedure: synovial biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of samples
Measured: 1 day
Secondary outcomes (4)
Tissue quality
assessed using Krenn's histological score
Measured: 1 month
number of adverse events
Measured: 1 year
Patient acceptability
using a visual analogue scale
Measured: 1 day
Cluster analysis of results from high-throughput experiments
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start30 Oct 2026
- Primary completion30 Oct 2030 (estimated)
- Study completion30 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Synovitis VillonodularStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Synovial sampling
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503821
- Sponsor's protocol ID
- RC24_0068
- Acronym
- SYVIPRO
- Status last verified
- Nov 2026
- First submitted
- 17 Mar 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synovial Tissue as a Biomarker in the Management of Pigmented Villonodular Synovitis
- ClinicalTrials.gov ID
- NCT07503821
- Acronym / sponsor ID
- SYVIPRO / RC24_0068
- Conditions
- Synovitis Villonodular
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 30 Oct 2026 (actual)
- Primary completion
- 30 Oct 2030 (estimated)
- Study completion
- 30 Oct 2030 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Synovial sampling
| Arm | Type | Receives |
|---|---|---|
| Synovial sampling | Experimental | Procedure: synovial biopsySynovial sampling on first visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient >18 years
- Diagnosis of localized or diffuse villonodular synovitis
- Referred for therapeutic management
- Affiliated with or benefiting from a social security scheme
Key exclusion criteria (6 listed)
- Pregnant women
- Nursing mothers
- Protected patients: patients under guardianship or curatorship, safeguard of justice
- Patients deprived of liberty
- Curative anticoagulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| synovial biopsySynovial samples are taken either : * immediately after surgery * during an ultrasound-guided synovial biopsy | Procedure or surgery | Synovial sampling |
Primary outcome
number of samples
Time frame: 1 day
4 secondary outcomes
Tissue quality
Time frame: 1 month
number of adverse events
Time frame: 1 year
Patient acceptability
Time frame: 1 day
Cluster analysis of results from high-throughput experiments
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Study of Vimseltinib (DCC-3014) in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing synovial biopsy in people with Synovitis Villonodular, run by Nantes University Hospital at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benoit Le Goff, PU-PH (02 40 08 48 25, benoit.legoff@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of samples (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.