Understanding and managing immune system disorders in patients
Immunodysregulation As an Expression of Underlying Inborn Errors of Immunity: Implementation of Diagnostics and Management of Pediatric and Adult Patients with Immune System Disorders
This study looks at how to better understand and manage inherited immune system disorders in both children and adults by collecting information from their tests and treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | N/A to 50 Years |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna, Bolgona) |
| Trial ID | NCT06773546 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on Inborn Errors of Immunity, a group of inherited diseases affecting the immune system. It aims to clinically and molecularly characterize both pediatric and adult patients with confirmed or suspected immune disorders. Evaluations include standard blood tests, lymphocyte typing, immunoglobulin levels, vaccination responses, and genetic investigations. Patients will be treated according to standard clinical practices while data is collected retrospectively and prospectively.
Who should consider this trial
Good fit: Ideal candidates include patients under 50 years old with confirmed or suspected Inborn Errors of Immunity.
Not a fit: Patients whose immunodeficiency is due to known non-immunological causes, such as chronic infections or immunosuppressive treatments, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostics and management strategies for patients with immune system disorders.
How similar studies have performed: Other studies have shown success in characterizing immune disorders, but this specific approach may provide novel insights into immunodysregulation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients with confirmed or suspected Inborn Errors of Immunity; * age \< 50 years at onset of clinical features suspected for Inborn Errors of Immunity; * obtaining informed consent from patients or parents/legal guardian of pediatric patients. Exclusion Criteria: • patients in whom infectious susceptibility and immunodysregulation can only be attributed to known non-immunological causes: acquired immunodeficiency secondary to chronic infections (HIV), and acquired immunodeficiency secondary to immunosuppressive treatment.
Where this trial is running
Bologna, Bolgona
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Bolgona, Italy (Recruiting)
Study contacts
- Principal investigator: Francesca Conti, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Francesca Conti
- Email: francesca.conti27@unibo.it
- Phone: 00390512144666
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.