Clinico-biological Collection to Investigate the Physiopathology of Systemic Autoimmune Diseases

NCT ID: NCT05251415

Last Updated: 2024-03-29

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

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-04

Study Completion Date

2032-04-04

Brief Summary

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The aim of this project is to start a biological and clinical collection of patients presenting systemic autoimmune disease. This collection will provide appropriate biological samples to identify new biomarkers and to be accessible to the medical, scientific and industrial communities for the identification of new therapeutic strategies

Detailed Description

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Autoimmune diseases group together less than a hundred different clinical entities which are for the most part rare pathologies but which, in combination, concern 5-8% of the adult population with a strong female predominance (FAI²R: the disease chain rare autoimmune and auto-inflammatory drugs, fai2r.org). The common denominator of all these diseases is based on the breakdown of self-tolerance which is the origin of self-reactivity and whose physiopathological mechanisms are still not fully understood, which generates numerous cross-sectional or fundamental studies. In addition to this complexity, there are significant inter-individual variabilities which lead to the definition of subgroups of patients on the basis of the clinical-biological profile and / or the response to treatments. Consequently and in view of the need to establish the diagnosis early and then to propose the best treatment in the perspective of an individualized medicine, the clinical, biological and genetic characteristics of these subgroups of patients must be explored in order to improve diagnostic and therapeutic capacities.

Conditions

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Lupus Erythematosus Scleroderma Myositis Vasculitis Inflammatory Bowel Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients suffering from autoimmune disease

Biological samples will be collected in the normal diagnosis and follow-up process. Only blood will be taken in larger quantity.

Blood sampling

Intervention Type BIOLOGICAL

Blood will be taken in larger quantity.

Interventions

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Blood sampling

Blood will be taken in larger quantity.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patients with rare systemic autoimmune diseases (lupus, scleroderma, myositis for example),
* Patients with atypical presentations of documented or probable systemic autoimmune diseases,
* Patients receiving, or likely to receive new, innovative therapies (new molecule on the market, gene therapy, cell therapy, etc.).

Exclusion Criteria

* Known anemia and hemoglobin \<10 g / dl
* Patients under protective supervision (guardianship, curators)
* Pregnant or breastfeeding woman
Minimum Eligible Age

6 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chloé BOST, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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Purpan University Hospital

Toulouse, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Chloé BOST, MD, PhD

Role: CONTACT

5 61 77 61 44 ext. 0033

Facility Contacts

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Chloé Bost, PharmD, PhD

Role: primary

5 61 77 61 44 ext. 0033

Other Identifiers

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RC31/21/0505

Identifier Type: -

Identifier Source: org_study_id

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