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

Sponsor
University Hospital, Brest (Other)
Overall Status
Recruiting
CT.gov ID
NCT05022420
Collaborator
(none)
400
Enrollment
8
Locations
13
Anticipated Duration (Months)
50
Patients Per Site
3.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    SAfety and TOlerance of the Biopsies in Auto-immune Rare dIseases
    Actual Study Start Date :
    Aug 19, 2021
    Anticipated Primary Completion Date :
    Sep 19, 2022
    Anticipated Study Completion Date :
    Sep 19, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. evaluation of the qualitiy of patient's information at inclusion [questionnaire at inclusion]

      standardized questionnaire at inclusion

    3. risk factor of sied effect of each biospy [standardized questionnaire at inclusion, day 7 and 30]

      standardized questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU d'ANGERS Angers France
    2 CHU de Bordeaux Bordeaux France 33000
    3 CHRU de Brest Brest France 29609
    4 CHU de LILLE Lille France 59037
    5 CHU de Marseille Marseille France
    6 Hôpital de la Salpétrière Paris France 75013
    7 CH de Quimper Quimper France 20007
    8 CHU de Tours Tours France

    Sponsors and Collaborators

    • University Hospital, Brest

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Brest
    ClinicalTrials.gov Identifier:
    NCT05022420
    Other Study ID Numbers:
    • SATORI (29BRC21.0089)
    First Posted:
    Aug 26, 2021
    Last Update Posted:
    Feb 25, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Rare Diseases

    Study Results

    No Results Posted as of Feb 25, 2022