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

NCT05022420 | Terminated

• 1 other identifier: SATORI (29BRC21.0089)
• Study Type: observational
• Target: 505
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Tolerance; Biopsy Site Itching

Outcome Measures

Primary Outcomes (1)

• tolerance of each type of biopsy

  tolerance based on a standardized patient 's questionnaire

  tolerance at day 7 after the biospy was performed

Secondary Outcomes (3)

• tolerance of each type of biopsy 30 days after

  tolerance at day 30 and at inclusion after the biospy was performed

• evaluation of the qualitiy of patient's information at inclusion

  questionnaire at inclusion

• risk factor of sied effect of each biospy

  standardized questionnaire at inclusion, day 7 and 30

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• biospy required for the diagnsis or follow up aged of more than 18 non opposition form

You may not qualify if:

• unable to consent demencia unable to fill the form and questionnaire patient Under juridical protection refusing to participate

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (8)

CHU d'ANGERS

Angers, France

Location

CHU de Bordeaux

Bordeaux, 33000, France

Location

CHRU de Brest

Brest, 29609, France

Location

CHU de LILLE

Lille, 59037, France

Location

CHU de Marseille

Marseille, France

Location

Hôpital de la Salpétrière

Paris, 75013, France

Location

CH de Quimper

Quimper, 20007, France

Location

CHU de Tours

Tours, France

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: August 26, 2021
• Study Start: August 19, 2021
• Primary Completion: March 16, 2025
• Study Completion: March 16, 2025
• Last Updated: June 26, 2026

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning one year and ending five years following the publication
• 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.

Locations

FR (8)