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New study aims to crack the code of autoimmune diseases

NCT ID NCT04902807

Knowledge-focused Sponsor: Institut National de la Santé Et de la Recherche Médicale, France Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

This study is collecting blood, urine, and stool samples from 500 children with autoimmune diseases and healthy controls. Researchers will analyze these samples to find molecular patterns that could help diagnose these conditions and guide treatment decisions. The goal is to create a tool that doctors can use to personalize care for patients with autoimmunity and inflammation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a tool that helps doctors diagnose and choose treatments for autoimmune diseases more accurately.
What could go wrong
This is an observational study, not testing a treatment. It may not directly improve patient outcomes, and the tool may take years to develop and validate.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

325 people

The number who actually took part.

Started

Sep 2021

Finished

Oct 2025

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with PIDs and autoimmunity/inflammation related to known and unknown genetic defects (ALPS, Cytopenia, Enteropathy-IBD, pSLE, JIA, FHL, CA-EBV, CID) and their healthy relatives (controls) will be recruited in 2 clinical services of Necker hospital: Paediatric Rhumatology Immuno Hematology department Department, and paediatric Paediatric Gastroenterology department Department. Unrelated controls will be recruited in the Paediatric Rhumatology Immuno Hematology Department, the Paediatric Gastroenterology Department,also be recruited in the Department of Paediatric Visceral and Urologic Surgery and the Department of Maxillofacial Surgery and Paediatric Plastic Surgery within patients hospitalised for a surgery and not affected by an immune-related disease or a cancer.

Ages

1 year to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

autoimmune disease autoimmune enteropathy autoimmune hemolytic anemia autoimmune hepatitis autoimmune lymphoproliferative syndrome autoimmune lymphoproliferative syndrome type 4 autoimmune polyendocrine syndrome type 1 autoimmune thrombocytopenia BENTA disease combined immunodeficiency Epstein-Barr virus-associated lymphoproliferative disorder Evans syndrome hemophagocytic syndrome hereditary hemophagocytic lymphohistiocytosis immune dysregulation-polyendocrinopathy-enteropathy-X-linked syndrome immunodeficiency 32B inborn error of immunity inflammatory bowel disease juvenile idiopathic arthritis Lymphohistiocytosis, Hemophagocytic Polyendocrinopathies, Autoimmune Primary Immunodeficiency Diseases Purpura, Thrombocytopenic, Idiopathic systemic lupus erythematosus type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

APECED Autoimmune anemia Autoimmune cytopenia Autoimmune diabetes Autoimmune diseases Autoimmune hepatitis Autoimmune lymphoproliferative syndrome Autoimmune rheumatologic disease Autoimmune thrombocytopenia BENTA Combined immunodeficiency EBV lymphoproliferation Enteropathy, autoimmune Hemophagocytic lymphohistiocytoses IBD IPEX Juvenile idiopathic arthritis Primary immunodeficiency Ras-associated autoimmune leucoproliferative disease Systemic lupus erythematosus

Contacts and locations

Locations

  • hôpital Necker Enfants Malades

    Paris, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.