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

Inflammatory Bowel Diseases Clinical Trial

— ESSAi  

Official title:

Constitution of a Collection of Biological Samples With the Aim of Carrying Out Clinico-biological and Pathophysiological Investigations of Systemic Autoimmune Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05251415
• Other study ID #: RC31/21/0505
• Status: Recruiting
• Start date: April 4, 2022
• Est. completion date: April 4, 2032

Study information

• Verified date: March 2024
• Source: University Hospital, Toulouse
• Contact: Chloé BOST, MD, PhD
• Phone: 5 61 77 61 44
• Email: bost.c[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: April 4, 2032
• Est. primary completion date: April 4, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Lupus Erythematosus
• Myositis
• Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Vasculitis

Intervention

Biological:
• Blood sampling
Blood will be taken in larger quantity.

Locations

Country	Name	City	State
France	Purpan University Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Constitution of a collection of biological samples and clinical-biological data from patients with autoimmune diseases	Prospective collection of all available biological samples and clinical data collected during the normal clinical care	through study completion, an average of 1 year
Secondary	Identification and / or validation of new biomarkers for diagnostic and / or prognostic purposes	Use of immune cells and / or biological liquids obtained from patients for cohort studies with new methods of screening (microarray, flow cytometry)	through study completion, an average of 1 year
Secondary	Identification and / or validation of new predictive biomarkers of relapse and / or response to treatment	Use of immune cells and / or biological liquids obtained from patients for cohort studies with new methods of screening (microarray, flow cytometry)	through study completion, an average of 1 year
Secondary	Identification of specificities in these patients in order to improve the diagnosis, treatment decisions and / or the pathophysiological understanding of these diseases	Use of immune cells and / or biological samples for transcriptomic and / or proteomic studies, or in order to be used in experimental animal models	through study completion, an average of 1 year
Secondary	Identification of the determinants of immune reconstitution after cell therapy	Exploring blood cell populations before and after cell therapy with flow cytometry	through study completion, an average of 1 year