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

October 20, 2020 updated by: Nantes University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

201

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49000
        • CHU d'Angers
      • Bordeaux, France, 33000
        • CHU de Bordeaux
      • Brest, France, 29000
        • CHU Brest
      • Caen, France, 14000
        • CHU Caen
      • Dijon, France, 21000
        • CHU de Dijon
      • La Roche-sur-Yon, France, 85000
        • CHD La Roche-sur-Yon
      • Marseille, France, 13000
        • AP-HM
      • Montpellier, France, 34000
        • CHU de Montpellier
      • Nancy, France, 54000
        • CHU de Nancy
      • Nice, France, 06000
        • CHU de Nice
      • Poitiers, France, 86000
        • CHU de Poitiers
      • Rennes, France, 35000
        • CHU de Rennes
      • Strasbourg, France, 67000
        • CHU de Strasbourg
      • Toulouse, France, 31000
        • CHU de Toulouse
    • Lariboisière
      • Paris, Lariboisière, France, 75475
        • AP-HP
    • Saint-Antoine
      • Paris, Saint-Antoine, France, 75012
        • AP-HP
    • Salpétrière
      • Paris, Salpétrière, France, 75013
        • AP-HP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Age under 18 year old, pregnancy, breastfeeding

Description

Inclusion Criteria:

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

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of cases where the synovial biopsy allows drawing a definite diagnosis
Time Frame: 10 days
Final diagnosis will be classified in 5 groups: infectious, crystal induced arthritis, tumoral, inflammatory rheumatisms, others (amyloidosis etc …)
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Indications, tolerance, complications, number and type of analysis for each sample, results of pathology, bacteriology, mycobacteriology
Time Frame: 1 month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Benoit Le Goff, CHU de Nantes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 14, 2018

Primary Completion (ACTUAL)

September 11, 2020

Study Completion (ACTUAL)

September 11, 2020

Study Registration Dates

First Submitted

January 15, 2018

First Submitted That Met QC Criteria

January 24, 2018

First Posted (ACTUAL)

January 31, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 20, 2020

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC17_0440

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Arthritis

Clinical Trials on US-guided synovial biopsy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe