NCT03417167

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Typical duration for all trials

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

February 14, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2020

Completed
Last Updated

October 22, 2020

Status Verified

January 1, 2018

Enrollment Period

2.6 years

First QC Date

January 15, 2018

Last Update Submit

October 20, 2020

Conditions

Keywords

synovial biopsyUS guided synovial biopsy

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

AP-HP

Paris, Saint-Antoine, 75012, France

Location

AP-HP

Paris, Salpétrière, 75013, France

Location

Chu d'Angers

Angers, 49000, France

Location

CHU de Bordeaux

Bordeaux, 33000, France

Location

Chu Brest

Brest, 29000, France

Location

CHU CAEN

Caen, 14000, France

Location

Chu de Dijon

Dijon, 21000, France

Location

CHD La Roche-sur-Yon

La Roche-sur-Yon, 85000, France

Location

AP-HM

Marseille, 13000, France

Location

Chu de Montpellier

Montpellier, 34000, France

Location

CHU de Nancy

Nancy, 54000, France

Location

CHU de Nice

Nice, 06000, France

Location

CHU de Poitiers

Poitiers, 86000, France

Location

Chu de Rennes

Rennes, 35000, France

Location

Chu de Strasbourg

Strasbourg, 67000, France

Location

Chu de Toulouse

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Benoit Le Goff

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

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

Locations