NCT04902807Completed
Conception of a Diagnosis, Prognosis and Therapeutic Decision Tool for Patients With Autoimmunity and Inflammation
Source: ClinicalTrials.gov · Last updated 18 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 325 (actual)
- First submitted
- 21 May 2021
- Start date
- 7 Sept 2021
- Primary completion date
- 14 May 2025
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
- Diseases
- Lupus (SLE), Type 1 diabetes
- NCT number
- NCT04902807
What you commit to
- Study type: Observational
- Participants enrolled: 325
- From 7 Sept 2021 to the primary completion date, 14 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Intake of antibiotics within 2 weeks prior inclusion
Other illness
- Cytotoxic cancer treatments
- antiviral treatments (HIV, hepatitis …)
- Short term life-threatening conditions
Other
- Absence of parent's or child consent form
- Individuals placed under judicial protection
Who the study is looking for
- 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.
Age in the registry: 1 year to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Necker Enfants Malades Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.