Understanding Monogenic Lupus in Children with Systemic Lupus Erythematosus
Screening for Monogenic Lupus in Patients With Childhood Onset Systemic Lupus Erythematosus
This study is trying to find out how common a specific type of lupus is in children with systemic lupus erythematosus and develop better ways to spot it early.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT04532541 on ClinicalTrials.gov |
What this trial studies
This observational study aims to determine the prevalence of monogenic lupus in children diagnosed with systemic lupus erythematosus (SLE) and to develop diagnostic strategies for its early detection. The study will involve approximately 200 patients aged from birth to 18 years who meet specific inclusion criteria, including established SLE diagnoses. Genetic analysis will be conducted alongside the collection of clinical data to better understand the relationship between genetic factors and childhood SLE. The findings could enhance early identification and treatment approaches for affected children.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 0 to 18 years who have been diagnosed with systemic lupus erythematosus.
Not a fit: Patients who do not have systemic lupus erythematosus or those lacking sufficient clinical data may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods and treatment strategies for children with monogenic lupus, potentially enhancing their health outcomes.
How similar studies have performed: While the concept of monogenic lupus is gaining recognition, this specific approach to studying its prevalence in childhood SLE is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Subjects who meet the following criteria will be allowed to participate in the study: 1. onset age: birth to 18 years; 2. meet the diagnostic criteria of SLE according to ACR(1997), or SLICC(2012), or EULAR/ACR (2019); 3. obtain parental consent. Exclusion Criteria: 1. Lack of clinical data; 2. Unable to finish the follow-up.
Where this trial is running
Shanghai, Shanghai
- Children's Hospital of Fudan University — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Yinv Gong
- Email: gongyinv@163.com
- Phone: +8615921439339
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.