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

Recruiting

• Conditions: Biopsy Site Itching; Tolerance

• Registration Number: NCT05022420
• Lead Sponsor: University Hospital, Brest

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.

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 Timeline

• Study Start: 2021-08-19
• Study First Submitted: 2021-08-25
• Study First Submitted QC: 2021-08-25
• Study First Posted: 2021-08-26
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-05
• Primary Completion: 2025-02-18
• Study Completion: 2025-02-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
tolerance of each type of biopsy	tolerance at day 7 after the biospy was performed	tolerance based on a standardized patient 's questionnaire

Secondary Outcome Measures

Name	Time	Method
tolerance of each type of biopsy 30 days after	tolerance at day 30 and at inclusion after the biospy was performed	tolerance based on a standardized patient 's questionnaire
evaluation of the qualitiy of patient's information at inclusion	questionnaire at inclusion	standardized questionnaire at inclusion
risk factor of sied effect of each biospy	standardized questionnaire at inclusion, day 7 and 30	standardized questionnaire

Trial Locations

Locations (8)

CHU d'ANGERS; 🇫🇷 Angers, France

CHU de LILLE; 🇫🇷 Lille, France

Hôpital de la Salpétrière; 🇫🇷 Paris, France

CHU de Tours; 🇫🇷 Tours, France

CHRU de Brest; 🇫🇷 Brest, France

CHU de Marseille; 🇫🇷 Marseille, France

CHU de Bordeaux; 🇫🇷 Bordeaux, France

CH de Quimper; 🇫🇷 Quimper, France