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

NCT ID: NCT05022420

Last Updated: 2024-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-19

Study Completion Date

2025-02-18

Brief Summary

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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

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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

Conditions

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Tolerance Biopsy Site Itching

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Salivary gland biospy,

100 Salivary gland biospy use for the diagnosis of sjogern disease or other auto-immune disease.

No interventions assigned to this group

muscular biopsy,

muscular biospy use for the diagnosis of muscular auto-immune disease.

No interventions assigned to this group

neuro muscular biospy

neuro muscular biospy use for the diagnosis of vasculitis,muscular auto-immune disease or neuro-muscumar auto-immune disease

No interventions assigned to this group

temporal arteries biospy

temporal arteries biospy uses for the diagnosis of giant cell arteritis

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU d'ANGERS

Angers, , France

Site Status RECRUITING

CHU de Bordeaux

Bordeaux, , France

Site Status RECRUITING

CHRU de Brest

Brest, , France

Site Status RECRUITING

CHU de LILLE

Lille, , France

Site Status RECRUITING

CHU de Marseille

Marseille, , France

Site Status NOT_YET_RECRUITING

Hôpital de la Salpétrière

Paris, , France

Site Status NOT_YET_RECRUITING

CH de Quimper

Quimper, , France

Site Status NOT_YET_RECRUITING

CHU de Tours

Tours, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Valérie Devauchelle-Pensec

Role: CONTACT

02-98-34-72-64

Alain Saraux

Role: CONTACT

02 98 34 72 64

Facility Contacts

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Geoffrey URBANSKI

Role: primary

Christophe RICHEZ RICHEZ

Role: primary

Valerie Devauchelle-Pensec

Role: primary

Eric HACHULLA

Role: primary

Emmanuelle CAMPANA-SALORT -

Role: primary

Yves ALLENBACH

Role: primary

Jérémy KERAËN

Role: primary

Guillermo CARVAJAL ALEGRIA

Role: primary

Other Identifiers

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SATORI (29BRC21.0089)

Identifier Type: -

Identifier Source: org_study_id

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