Conception of a Diagnosis, Prognosis and Therapeutic Decision Tool for Patients With Autoimmunity and Inflammation

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Observational
SUMMARY

The main objective of this study is to generate diagnosis and therapeutic-decision tools through the identification of molecular causes of PIDs with autoimmunity/inflammation and the variability in disease outcome at the transcriptional level using a combination of omics signatures (transcriptomics, epigenomics, proteomics, metagenomics, metabolomics and lipidomics).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 18
Healthy Volunteers: f
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• Individuals aged\<18 y/o.

• Individuals \> 6 kg

• Individuals not affected by an immune-related disease or not affected by cancer

• Individuals whose parents have signed an enlightened consent.

• Individuals with health insurance.

• Patients treated at Necker hospital with PIDs and autoimmunity/inflammation related to known genetic defects (cytopenia, Enteropathy Inflammatory bowel disease (IBD), Systemic Lupus Erythematosus (SLE), Juvenile Idiopathic Arthritis (JIA), Familial Hemophagocytic Lymphohistiocytosis (FHL), chronic EBV infection associated (Ca-EBV) with EBV-infected T and/or Natural Killer (NK) cells and with a high risk to develop macrophage activation syndrome similar to FHL. See table below for diagnosis inclusion criteria.

• Individuals aged\<18 y/o.

• Individuals \> 9 kg

• Patients whose parents have signed an enlightened consent.

Locations
Other Locations
France
hôpital Necker Enfants Malades
RECRUITING
Paris
Contact Information
Primary
Frédéric Rieux-Laucat
frederic.rieux-laucat@inserm.fr
+33142754200
Time Frame
Start Date: 2021-09-07
Estimated Completion Date: 2026-06
Participants
Target number of participants: 500
Treatments
Patients
based on the potential for inclusion of patient's cohort followed in Necker hospital with PIDs and poly-autoimmunity related to known genetic defects. Recruitments will be made at Pediatric Rheumatology Immuno Hematology department, and paediatric Gastroenterology department (n=250).~Collection of blood, urine and stools at inclusion and blood at 12 months consultation/ follow-up.
Patients' relatives (control)
Brothers or sisters of the patients (n=125). Collection of blood, urine and stools at inclusion.
Patients with unrelated diseases (control)
Recruitments will be made at the Paediatric Gastroenterology Department, in the Department of Paediatric Visceral and Urologic Surgery and the Department of Maxillofacial Surgery and Paediatric Plastic Surgery at Necker's Hospital. Participants will be included if not diagnosed PIDs and poly-autoimmunity (n=125).~Collection of blood, urine and stools.
Sponsors
Leads: Institut National de la Santé Et de la Recherche Médicale, France

This content was sourced from clinicaltrials.gov