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NCT05022420 Clinical Trial

SAfety and TOlerance of the Biopsies in Auto-immune Rare dIseases

Tolerance Clinical Trial

— SATORI  

Official title:
SAfety and TOlerance of the Biopsies in Auto-immune Rare dIseases

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05022420
Other study ID # SATORI (29BRC21.0089)
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 19, 2021
Est. completion date February 18, 2025

Study information
Verified date April 2024
Source University Hospital, Brest
Contact Valérie Devauchelle-Pensec
Phone 02-98-34-72-64
Email valerie.devauchelle-pensec@chu-brest.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Biopsies are performed in several autoimmune diseases to diagnose or classify them Tolerance and information of the patients have been poorly evlauated our objective is to evaluate tolerance and information of the patients after the biopsies for salivary gland, temporal arteries and neuromuscular.

Description:

patinets that benefited of arterial temporal biospy or salivary gland biospy or muscuar biopsy or neuro muscular biospy for his auto -mmune disease will be included and fill standardized questionnaires concerning tolerance, information and side effect at inclusion , day 7 and day 30 after the biopsy data will be analysed to evaluate information, tolerance and risk factor af side effect

Recruitment information / eligibility
Status Recruiting
Enrollment 600
Est. completion date February 18, 2025
Est. primary completion date February 18, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - biospy required for the diagnsis or follow up aged of more than 18 non opposition form Exclusion Criteria: - unable to consent demencia unable to fill the form and questionnaire patient Under juridical protection refusing to participate

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CHU d'ANGERS Angers
France CHU de Bordeaux Bordeaux
France CHRU de Brest Brest
France CHU de LILLE Lille
France CHU de Marseille Marseille
France Hôpital de la Salpétrière Paris
France CH de Quimper Quimper
France CHU de Tours Tours

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary tolerance of each type of biopsy tolerance based on a standardized patient 's questionnaire tolerance at day 7 after the biospy was performed
Secondary tolerance of each type of biopsy 30 days after tolerance based on a standardized patient 's questionnaire tolerance at day 30 and at inclusion after the biospy was performed
Secondary evaluation of the qualitiy of patient's information at inclusion standardized questionnaire at inclusion questionnaire at inclusion
Secondary risk factor of sied effect of each biospy standardized questionnaire standardized questionnaire at inclusion, day 7 and 30
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