Identifying biomarkers for severe lupus using multi-omics analysis
Screening Biomarkers for Severe Lupus Based on Multi-omics Studies
This study is testing if new genetic markers can help doctors better diagnose and treat severe lupus by comparing patients with lupus to healthy people and those with other similar diseases.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 152 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Academic / other |
| Locations | 1 site (Nanjing) |
| Trial ID | NCT05539001 on ClinicalTrials.gov |
What this trial studies
This study aims to improve the diagnosis and treatment of systemic lupus erythematosus (SLE) by utilizing RNA sequencing and chromatin open sequencing to identify disease-causing genes. By comparing data from lupus patients with normal controls and those with other rheumatic diseases, the researchers will analyze changes in biomarkers over time. Machine learning methods will be employed to develop a predictive model for severe lupus outcomes, ultimately aiming to establish an early diagnosis system that can reduce mortality rates in patients experiencing treatment failures.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-60 who meet at least four of the American College of Rheumatology's classification criteria for systemic lupus erythematosus.
Not a fit: Patients with other autoimmune diseases, organ failure, or severe infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate diagnoses of severe lupus, improving patient outcomes and reducing mortality.
How similar studies have performed: Other studies have shown promise in using multi-omics approaches for understanding autoimmune diseases, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:All of the following criteria must be met at the same time 1. Meet at least 4 of the 11 systemic lupus erythematosus(SLE) classification criteria established by the American College of Rheumatology (ACR) in 1997; 2. The age range is 18-60 years; 3. Sign the informed consent and be willing to provide blood samples Exclusion Criteria:Any meeting any of the following criteria will be excluded. 1. Have other autoimmune diseases other than SLE: including dermatomyositis/polymyositis, mixed connective tissue disease, systemic sclerosis, rheumatoid arthritis, etc., but not including secondary Sjogren's syndrome symptomatic patients. 2. Those with organ failure; or those with an estimated survival period of less than 4 weeks; 3. Combined with various infections (at least one blood or secretion culture result is positive, or at least one second-generation sequencing detects the pathogen sequence and conforms to clinical manifestations, or is clinically judged by a physician as infection); 4. Combined pregnancy.
Where this trial is running
Nanjing
- Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School — Nanjing, China (Recruiting)
Study contacts
- Study coordinator: xuebing Feng, director
- Email: zjj18805195759@163.com
- Phone: 18805195759
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.