Indications and Interest of US-guided Synovial Biopsies Performed in Clinical Practice
BIOPSYN
"Interest of Synovial Biopsy in the Etiological Assessment of Arthritis of Undetermined Origin: Multicenter Prospective Series"
1 other identifier
observational
201
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2018
Typical duration for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2018
CompletedFirst Posted
Study publicly available on registry
January 31, 2018
CompletedStudy Start
First participant enrolled
February 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 11, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 11, 2020
CompletedOctober 22, 2020
January 1, 2018
2.6 years
January 15, 2018
October 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Indications, tolerance, complications, number and type of analysis for each sample, results of pathology, bacteriology, mycobacteriology
1 month
Interventions
Needle Synovial biopsy performed using a Tru-cut® device.
Eligibility Criteria
Age under 18 year old, pregnancy, breastfeeding
You may qualify if:
- All patients undergoing an US-guided synovial biopsy in clinical practice in the context of an arthritis of unknown origin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
AP-HP
Paris, Lariboisière, 75475, France
AP-HP
Paris, Saint-Antoine, 75012, France
AP-HP
Paris, Salpétrière, 75013, France
Chu d'Angers
Angers, 49000, France
CHU de Bordeaux
Bordeaux, 33000, France
Chu Brest
Brest, 29000, France
CHU CAEN
Caen, 14000, France
Chu de Dijon
Dijon, 21000, France
CHD La Roche-sur-Yon
La Roche-sur-Yon, 85000, France
AP-HM
Marseille, 13000, France
Chu de Montpellier
Montpellier, 34000, France
CHU de Nancy
Nancy, 54000, France
CHU de Nice
Nice, 06000, France
CHU de Poitiers
Poitiers, 86000, France
Chu de Rennes
Rennes, 35000, France
Chu de Strasbourg
Strasbourg, 67000, France
Chu de Toulouse
Toulouse, 31000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Benoit Le Goff
Nantes University Hospital
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2018
First Posted
January 31, 2018
Study Start
February 14, 2018
Primary Completion
September 11, 2020
Study Completion
September 11, 2020
Last Updated
October 22, 2020
Record last verified: 2018-01