Clinical trial NCT03417167: Indications and Interest of US-guided Synovial Biopsies Performed in Clinical Practice
Official title: "Interest of Synovial Biopsy in the Etiological Assessment of Arthritis of Undetermined Origin: Multicenter Prospective Series"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis
Keywords: synovial biopsy
US guided synovial biopsy
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Age under 18 year old, pregnancy, breastfeeding

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Primary outcomes:
measure: number of cases where the synovial biopsy allows drawing a definite diagnosis
timeFrame: 10 days
Secondary outcomes:
measure: Indications, tolerance, complications, number and type of analysis for each sample, results of pathology, bacteriology, mycobacteriology
timeFrame: 1 month
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP
state: Lariboisière
city: Paris
country: France
facility: AP-HP
state: Saint-Antoine
city: Paris
country: France
facility: AP-HP
state: Salpétrière
city: Angers
country: France
facility: Chu d'Angers
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Brest
country: France
facility: Chu Brest
city: Caen
country: France
facility: CHU CAEN
city: Dijon
country: France
facility: Chu de Dijon
city: La Roche-sur-Yon
country: France
facility: CHD La Roche-sur-Yon
city: Marseille
country: France
facility: AP-HM
city: Montpellier
country: France
facility: Chu de Montpellier
city: Nancy
country: France
facility: CHU de Nancy
city: Nice
country: France
facility: CHU de Nice
city: Poitiers
country: France
facility: CHU de Poitiers
city: Rennes
country: France
facility: Chu de Rennes
city: Strasbourg
country: France
facility: Chu de Strasbourg
city: Toulouse
country: France
facility: Chu de Toulouse
Study officials:
affiliation: Nantes University Hospital
name: Benoit Le Goff
role: PRINCIPAL_INVESTIGATOR
References: