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

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.

Study Overview

• Status: Recruiting
• Conditions: Tolerance; Biopsy Site Itching

Detailed 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

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Valérie Devauchelle-Pensec; Phone Number: 02-98-34-72-64; Email: valerie.devauchelle-pensec@chu-brest.fr
• Study Contact Backup: Name: Alain Saraux; Phone Number: 02 98 34 72 64; Email: alain.saraux@chu-brest.fr

Study Locations

• France
  • Angers, France
    • Recruiting
    • CHU d'Angers
    • Contact: Geoffrey URBANSKI
  • Bordeaux, France, 33000
    • Recruiting
    • Chu de Bordeaux
    • Contact: Christophe RICHEZ RICHEZ
  • Brest, France, 29609
    • Recruiting
    • CHRU de Brest
    • Contact: Valerie Devauchelle-Pensec; Email: valerie.devauchelle-pensec@chu-brest.fr
  • Lille, France, 59037
    • Recruiting
    • CHU de LILLE
    • Contact: Eric Hachulla
  • Marseille, France
    • Not yet recruiting
    • CHU de Marseille
    • Contact: Emmanuelle CAMPANA-SALORT -
  • Paris, France, 75013
    • Not yet recruiting
    • Hôpital de la Salpêtrière
    • Contact: Yves ALLENBACH
  • Quimper, France, 20007
    • Not yet recruiting
    • CH de Quimper
    • Contact: Jérémy KERAËN; Email: jeremy.keraen@ch-cornouaille.fr
  • Tours, France
    • Recruiting
    • CHU de Tours
    • Contact: Guillermo CARVAJAL ALEGRIA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

all patients that underwent a biospy for his auto-immune rare disease

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Salivary gland biospy,; 100 Salivary gland biospy use for the diagnosis of sjogern disease or other auto-immune disease.
muscular biopsy,; muscular biospy use for the diagnosis of muscular auto-immune disease.
neuro muscular biospy; neuro muscular biospy use for the diagnosis of vasculitis,muscular auto-immune disease or neuro-muscumar auto-immune disease
temporal arteries biospy; temporal arteries biospy uses for the diagnosis of giant cell arteritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tolerance of each type of biopsy	tolerance based on a standardized patient 's questionnaire	tolerance at day 7 after the biospy was performed

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
evaluation of the qualitiy of patient's information at inclusion	standardized questionnaire at inclusion	questionnaire at inclusion
risk factor of sied effect of each biospy	standardized questionnaire	standardized questionnaire at inclusion, day 7 and 30

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2021
• Primary Completion (Estimated): February 18, 2025
• Study Completion (Estimated): February 18, 2025

Study Registration Dates

• First Submitted: August 25, 2021
• First Submitted That Met QC Criteria: August 25, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Rare Diseases
• Other Study ID Numbers: SATORI (29BRC21.0089)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning one year and ending five years following the publication
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No