Conception of a Diagnosis, Prognosis and Therapeutic Decision Tool for Patients With Autoimmunity and Inflammation
Recruiting · NCT04902807 · Observational (researchers observe without assigning treatment) · Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
View the official record on ClinicalTrials.gov →Interventions studied
Collection of samples
What this trial is about
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).
Who can take part
Age range
1 Year to 18 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- for controls (patients relatives and unrelated subjects):
- 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.
- Inclusion criteria for patients
- 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.
Exclusion criteria
- Intake of antibiotics within 2 weeks prior inclusion
- Absence of parent's or child consent form
- Cytotoxic cancer treatments
- antiviral treatments (HIV, hepatitis …)
- Short term life-threatening conditions
- Individuals placed under judicial protection
Where it is running
1 location listed.
- hôpital Necker Enfants Malades - Paris, France