Monogenic Lupus in Childhood Onset Systemic Lupus Erythematosus
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| ClinicalTrials.gov Identifier: NCT04532541 |
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Recruitment Status :
Recruiting
First Posted : August 31, 2020
Last Update Posted : March 1, 2023
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| Tracking Information | |||||||||
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| First Submitted Date | August 26, 2020 | ||||||||
| First Posted Date | August 31, 2020 | ||||||||
| Last Update Posted Date | March 1, 2023 | ||||||||
| Actual Study Start Date | November 25, 2020 | ||||||||
| Estimated Primary Completion Date | September 30, 2025 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Incidence of Monogenic lupus in childhood onset SLE [ Time Frame: Gene test will be conducted at the time of enrollment. ] The concept of "Monogenic Lupus" has been proposed internationally, diagnosed by gene test among patients with typical SLE or lupus-like syndrome, and more than 30 single gene variants have been currently found to be related to the onset of SLE. This study intends to detect monogenic lupus in patients with childhood-onset SLE through gene test and bioinformatic analysis.
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Monogenic Lupus in Childhood Onset Systemic Lupus Erythematosus | ||||||||
| Official Title | Screening for Monogenic Lupus in Patients With Childhood Onset Systemic Lupus Erythematosus | ||||||||
| Brief Summary | The purpose of this study is to unravel the proportion of monogenic lupus in children onset Systemic lupus erythematosus (SLE), and to find out the diagnostic strategy for early detection of monogenic lupus. | ||||||||
| Detailed Description | Childhood Systemic Lupus Erythematosus (SLE) is a common autoimmune disease in children, with a high incidence in Asia. Compared with adult SLE, childhood SLE is more likely to involve multiple systems, the treatment is more difficult, and mortality is relatively high. With the improvement of diagnosis and treatment of SLE, the prognosis of children with SLE continues to improve, but there are still a small number of patients who are ineffective to existing treatments. The pathogenesis of SLE is complicated, and more and more evidences confirm that genetic factors are involved in the pathogenesis of SLE. In recent years, the concept of "Monogenic Lupus" has been proposed internationally, and more than 30 single gene variants have been found to be related to the onset of SLE. Such patients are clinically in line with typical SLE or lupus-like syndrome, with common characteristics of a very young age of onset (mostly in infants and young children), and/or a family history of rheumatic immune diseases. It is a huge difficulty to early identify these patients at present, and it has not been generally accepted in the field of rheumatology in China. In this research, about 200 patients with childhood onset SLE that meet the criteria for inclusion and exclusion were tested for gene analysis, and clinical data were collected and entered into the SLE cohort database. The incidence of monogenic lupus in childhood onset SLE will be unraveled. Based on clinical key words, such as early onset, male, family history of rheumatic diseases, blood system involvement, kidney involvement, the incidence of monogenic lupus in these single or multiple keyword combination will be calculated and compared to obtain an early, cost-effective diagnosis strategy for monogenic lupus. |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: EDTA anticoagulated peripheral blood is obtained from patients with childhood onset SLE and their biological parents. Samples are performed after parents' information and consent.
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| Sampling Method | Probability Sample | ||||||||
| Study Population | Participants in this group were derived from patients diagnosed with SLE at an age of less than 18 years old, and these patients were hospitalized in our center. | ||||||||
| Condition |
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| Intervention | Other: Monogenic lupus screening
This is an observational study, and there is no intervention. This study intends to obtain the incidence of monogenic lupus in childhood onset SLE through gene test and bioinformatic analysis.
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| Study Groups/Cohorts | Patients with childhood onset SLE
Participants in this group were derived from patients diagnosed with SLE at an age of less than 18 years old, and these patients were hospitalized in our center. Peripheral blood was collected from the patient and their biological parents for gene analysis to obtain the overall incidence of monogenic lupus in the cohort.
Intervention: Other: Monogenic lupus screening
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
200 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | September 30, 2025 | ||||||||
| Estimated Primary Completion Date | September 30, 2025 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria: Subjects who meet the following criteria will be allowed to participate in the study:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | up to 18 Years (Child, Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04532541 | ||||||||
| Other Study ID Numbers | Sunli-1 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Current Responsible Party | Children's Hospital of Fudan University | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor | Children's Hospital of Fudan University | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators | Not Provided | ||||||||
| PRS Account | Children's Hospital of Fudan University | ||||||||
| Verification Date | February 2023 | ||||||||