Collection of biological samples for rare pediatric autoimmune and autoinflammatory diseases
Biocollection for the Study of Genetic and Immunological Abnormalities in Rare Pediatric-onset Autoimmune and Auto Inflammatory Diseases
This study is collecting blood and tissue samples from kids with rare autoimmune diseases to help researchers learn more about these conditions and improve diagnosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 1 Year and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 13 sites (Bron, Bron and 12 other locations) |
| Trial ID | NCT06435468 on ClinicalTrials.gov |
What this trial studies
This study focuses on creating a biological collection of samples from patients with rare pediatric-onset autoimmune and autoinflammatory diseases, such as systemic lupus and juvenile dermatomyositis. It aims to gather primary cells, DNA, RNA, lymphoblastic lines, and serum to facilitate research into the genetic and immunological abnormalities associated with these conditions. By addressing the challenges posed by the rarity of these diseases and the limited availability of biological samples, the study seeks to enhance understanding and diagnosis of these severe conditions that often begin in childhood.
Who should consider this trial
Good fit: Ideal candidates include minors or adults with rare dysimmune diseases that began in childhood, as well as their relatives.
Not a fit: Patients with common autoimmune diseases or those whose conditions do not meet the rare disease criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and understanding of rare pediatric autoimmune and autoinflammatory diseases.
How similar studies have performed: Other studies focusing on rare diseases have shown promise in advancing understanding and treatment, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients * minor or adult patient of any age with a rare dysimmune disease characterized by autoimmunity or auto-inflammation or early lymphoproliferation, having started in childhood (\<18 years), or syndromic or familial * relative of a minor or adult patient with a rare dysimmune disease characterized by autoimmunity or auto-inflammation or early lymphoproliferation, having started in childhood (\<18 years of age) or syndromic or familial, * weight greater than 5 kg * Patient/parents/guardians who were informed of the study and signed the consent form. * patient affiliated to a social security scheme Healthy volunteer participants * minor or adult participants with no age restrictions * weight over 5 kg * Subject /Parents/guardians who were informed of the study and signed a consent form. * Patient affiliated to a social security scheme Exclusion Criteria: Patients \- Subjects /Parents/guardians, refusing to participate in the study Healthy volunteer participants : * active infection (viral, bacterial, parasitic) * history of neoplasia (\< 5 years) or current neoplasia * participants with a personal or family history of autoimmune disease * immunocompromised participant (immune deficiency or transplant recipient) * Subjects/parents/guardians refusing to participate in the study * Adults under legal protection (guardianship, curatorship)
Where this trial is running
Bron, Bron and 12 other locations
- Service de rhumatologie pédiatrique Hôpital Femme-Mère-enfant — Bron, Bron, France (Recruiting)
- Hôpital Jeanne de Flandre (CHU de Lille) — Lille, Lille, France (Not_yet_recruiting)
- Hôpital Claude Huriez (CHU de Lille) — Lille, Lille, France (Not_yet_recruiting)
- Hôpital Archet 2 — Nice, Nice, France (Not_yet_recruiting)
- Hôpital Necker-Enfants Malades (AP-HP) — Paris, Paris, France (Not_yet_recruiting)
- Hôpital Robert Debré (AP-HP) — Paris, Paris, France (Not_yet_recruiting)
- Hôpital Kremlin-Bicêtre (AP-HP) — Paris, Paris, France (Not_yet_recruiting)
- Hôpital Nord (CHU ST-Etienne) — Saint-Etienne, Saint Etienne, France (Not_yet_recruiting)
- Hôpital Couple Enfant — Grenoble, France (Not_yet_recruiting)
- Dr Isabelle MELKI — Paris, France (Recruiting)
- CLCC Henri Becquerel — Rouen, France (Not_yet_recruiting)
- Pr Ariane ZALOSZYC — Strasbourg, France (Recruiting)
- Dr Vanessa Remy-Piccolo — Villefranche-sur-Saône, France (Recruiting)
Study contacts
- Study coordinator: BELOT Alexandre, Pr
- Email: Alexandre.belot@chu-lyon.fr
- Phone: + 33 4 27 85 61 26
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.