NCT04902807 Conception of a Diagnosis, Prognosis and Therapeutic Decision Tool for Patients With Autoimmunity and Inflammation
| NCT ID | NCT04902807 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France |
| Condition | Autoimmune Lymphoproliferative Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2021-09-07 |
| Primary Completion | 2025-05-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2021-09-07 with a primary completion date of 2025-05-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frédéric Rieux-Laucat
PRINCIPAL INVESTIGATOR
Institut Imagine
Frequently Asked Questions
Who can join the NCT04902807 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 18 Years, studying Autoimmune Lymphoproliferative Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04902807 currently recruiting?
Yes, NCT04902807 is actively recruiting participants. Contact the research team at frederic.rieux-laucat@inserm.fr for enrollment information.
Where is the NCT04902807 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT04902807 clinical trial?
NCT04902807 is sponsored by Institut National de la Santé Et de la Recherche Médicale, France. The principal investigator is Frédéric Rieux-Laucat at Institut Imagine. The trial plans to enroll 500 participants.