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

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Recruiting
CT.gov ID
NCT05251415
Collaborator
(none)
3,000
1
119.4
25.1

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Biological: Blood sampling

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
3000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Constitution of a Collection of Biological Samples With the Aim of Carrying Out Clinico-biological and Pathophysiological Investigations of Systemic Autoimmune Diseases
Actual Study Start Date :
Apr 13, 2022
Anticipated Primary Completion Date :
Mar 25, 2027
Anticipated Study Completion Date :
Mar 25, 2032

Arms and Interventions

Arm Intervention/Treatment
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.

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

Outcome Measures

Primary Outcome Measures

  1. Constitution of a collection of biological samples and clinical-biological data from patients with autoimmune diseases [through study completion, an average of 1 year]

    Prospective collection of all available biological samples and clinical data collected during the normal clinical care

Secondary Outcome Measures

  1. Identification and / or validation of new biomarkers for diagnostic and / or prognostic purposes [through study completion, an average of 1 year]

    Use of immune cells and / or biological liquids obtained from patients for cohort studies with new methods of screening (microarray, flow cytometry)

  2. Identification and / or validation of new predictive biomarkers of relapse and / or response to treatment [through study completion, an average of 1 year]

    Use of immune cells and / or biological liquids obtained from patients for cohort studies with new methods of screening (microarray, flow cytometry)

  3. Identification of specificities in these patients in order to improve the diagnosis, treatment decisions and / or the pathophysiological understanding of these diseases [through study completion, an average of 1 year]

    Use of immune cells and / or biological samples for transcriptomic and / or proteomic studies, or in order to be used in experimental animal models

  4. Identification of the determinants of immune reconstitution after cell therapy [through study completion, an average of 1 year]

    Exploring blood cell populations before and after cell therapy with flow cytometry

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Purpan University Hospital Toulouse France 31059

Sponsors and Collaborators

  • University Hospital, Toulouse

Investigators

  • Principal Investigator: Chloé BOST, MD, PhD, University Hospital, Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT05251415
Other Study ID Numbers:
  • RC31/21/0505
First Posted:
Feb 22, 2022
Last Update Posted:
May 24, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Toulouse
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 24, 2022