Indications and Interest of US-guided Synovial Biopsies Performed in Clinical Practice

Arthritis Clinical Trial

— BIOPSYN  

Official title:

"Interest of Synovial Biopsy in the Etiological Assessment of Arthritis of Undetermined Origin: Multicenter Prospective Series"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03417167
• Other study ID #: RC17_0440
• Status: Completed
• Start date: February 14, 2018
• Est. completion date: September 11, 2020

Study information

• Verified date: January 2018
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Synovial biopsies are now routinely performed both in research and in clinical practice. The developments of ultrasound (US) and of US-guided needle biopsies devices have facilitated their use and tolerance by the patients. However, their interest in clinical practice in the context of an undifferentiated arthritis remains debated.

Description:

In this study, the investigators will collect all the synovial biopsies performed in clinical practice in 18 Rheumatology Unit throughout France. All the participants received a standardized training on US-guided synovial biopsies. For each biopsy, the indications, clinical presentation, procedure (length, tolerance), biopsy results (Pathology, bacteriology, etc ...) will be collected in a Clinical Research Form. The investigator will determine the number of cases where the synovial biopsy allows drawing a definite diagnosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: September 11, 2020
• Est. primary completion date: September 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

All patients undergoing an US-guided synovial biopsy in clinical practice in the context of an arthritis of unknown origin Exclusion Criteria:

Related Conditions & MeSH terms

• Arthritis

Intervention

Other:
• US-guided synovial biopsy
Needle Synovial biopsy performed using a Tru-cut® device.

Locations

Country	Name	City	State
France	Chu d'Angers	Angers
France	CHU de Bordeaux	Bordeaux
France	Chu Brest	Brest
France	CHU CAEN	Caen
France	Chu de Dijon	Dijon
France	CHD La Roche-sur-Yon	La Roche-sur-Yon
France	AP-HM	Marseille
France	Chu de Montpellier	Montpellier
France	CHU de Nancy	Nancy
France	CHU de Nice	Nice
France	AP-HP	Paris	Lariboisière
France	AP-HP	Paris	Saint-Antoine
France	AP-HP	Paris	Salpétrière
France	CHU de Poitiers	Poitiers
France	Chu de Rennes	Rennes
France	Chu de Strasbourg	Strasbourg
France	Chu de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of cases where the synovial biopsy allows drawing a definite diagnosis	Final diagnosis will be classified in 5 groups: infectious, crystal induced arthritis, tumoral, inflammatory rheumatisms, others (amyloidosis etc …)	10 days
Secondary	Indications, tolerance, complications, number and type of analysis for each sample, results of pathology, bacteriology, mycobacteriology	For each biopsy, the indications, clinical presentation, procedure (length, tolerance), biopsy results (Pathology, bacteriology, etc ...) will be collected in a Clinical Research Form.	1 month