Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03417167
Recruitment Status : Recruiting
First Posted : January 31, 2018
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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.

Condition or disease Intervention/treatment
Arthritis Other: US-guided synovial biopsy

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: "Interest of Synovial Biopsy in the Etiological Assessment of Arthritis of Undetermined Origin: Multicenter Prospective Series"
Actual Study Start Date : February 14, 2018
Estimated Primary Completion Date : February 14, 2021
Estimated Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis Biopsy


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


Primary Outcome Measures :
  1. 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 …)


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Age under 18 year old, pregnancy, breastfeeding
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417167


Contacts
Layout table for location contacts
Contact: Benoit Le Goff, PH 02.40.08.48.21 benoitlegoff@chu-nantes.fr
Contact: Peggy Ageneau 02.40.08.48.54 peggy.ageneau@chu-nantes.fr

Locations
Layout table for location information
France
AP-HP Recruiting
Paris, Lariboisière, France, 75475
Contact: Jérémy Maillet       Maillet.jerem@gmail.com   
AP-HP Recruiting
Paris, Saint-Antoine, France, 75012
Contact: Karine Louati       Karine.louati@aphp.fr   
AP-HP Recruiting
Paris, Salpétrière, France, 75013
Contact: Frédérique Gandjbakhch       frederique.gandjbakhch@aphp.fr   
Chu d'Angers Recruiting
Angers, France, 49000
Contact: Emmanuel HOPPE       EmHoppe@chu-angers.fr   
CHU de Bordeaux Not yet recruiting
Bordeaux, France, 33000
Contact: Nicolas Poursac       nicolas.poursac@chu-bordeaux.fr   
Chu Brest Recruiting
Brest, France, 29000
Contact: Dewi Guellec       dewiguellec@hotmail.fr   
CHU CAEN Recruiting
Caen, France, 14000
Contact: Johan Cesini       cesini-j@chu-caen.fr   
Chu de Dijon Recruiting
Dijon, France, 21000
Contact: Paul Ornetti       paul.ornetti@chu-dijon.fr   
CHD La Roche-sur-Yon Recruiting
La Roche-sur-Yon, France, 85000
Contact: Grégoire Cormier       gregoire.cormier@chd-vendee.fr   
AP-HM Recruiting
Marseille, France, 13000
Contact: Sophie Trijau       Sophie.trijau@ap-hm.fr   
Chu de Montpellier Recruiting
Montpellier, France, 34000
Contact: Gaël Mouterde       g-mouterde@chu-montpellier.fr   
CHU de Nancy Recruiting
Nancy, France, 54000
Contact: Damien LOEUILLE       d.loeuille@chru-nancy.fr   
CHU de Nice Recruiting
Nice, France, 06000
Contact: Christian Roux       ROUX.C2@chu-nice.fr   
CHU de Poitiers Not yet recruiting
Poitiers, France, 86000
Contact: Rachel Brault       Rachel.brault@chu-poitiers.fr   
Chu de Rennes Recruiting
Rennes, France, 35000
Contact: Jean-David ALBERT       Jean-david.albert@chu-rennes.fr   
Chu de Strasbourg Recruiting
Strasbourg, France, 67000
Contact: Emmanuel CHATELUS       emmanuel.chatelus@chru-strasbourg.fr   
Chu de Toulouse Recruiting
Toulouse, France, 31000
Contact: Bénédicte Jamard       jamard.b@chu-toulouse.fr   
Sponsors and Collaborators
Nantes University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Benoit Le Goff CHU de Nantes
Layout table for additonal information
Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03417167    
Other Study ID Numbers: RC17_0440
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: January 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
synovial biopsy
US guided synovial biopsy
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Joint Diseases
Musculoskeletal Diseases