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

March 28, 2024 updated by: University Hospital, Toulouse

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Toulouse, France, 31059
        • Recruiting
        • Purpan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with autoimmune diseases

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Constitution of a collection of biological samples and clinical-biological data from patients with autoimmune diseases
Time Frame: through study completion, an average of 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification and / or validation of new biomarkers for diagnostic and / or prognostic purposes
Time Frame: 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)
through study completion, an average of 1 year
Identification and / or validation of new predictive biomarkers of relapse and / or response to treatment
Time Frame: 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)
through study completion, an average of 1 year
Identification of specificities in these patients in order to improve the diagnosis, treatment decisions and / or the pathophysiological understanding of these diseases
Time Frame: 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
through study completion, an average of 1 year
Identification of the determinants of immune reconstitution after cell therapy
Time Frame: through study completion, an average of 1 year
Exploring blood cell populations before and after cell therapy with flow cytometry
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2022

Primary Completion (Estimated)

April 4, 2027

Study Completion (Estimated)

April 4, 2032

Study Registration Dates

First Submitted

January 24, 2022

First Submitted That Met QC Criteria

February 11, 2022

First Posted (Actual)

February 22, 2022

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/21/0505

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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