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History of Changes for Study: NCT04532541
Monogenic Lupus in Childhood Onset Systemic Lupus Erythematosus
Latest version (submitted February 15, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 28, 2020 None (earliest Version on record)
2 January 11, 2021 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 February 15, 2022 Contacts/Locations and Study Status
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Study NCT04532541
Submitted Date:  August 28, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: Sunli-1
Brief Title: Monogenic Lupus in Childhood Onset Systemic Lupus Erythematosus
Official Title: Screening for Monogenic Lupus in Patients With Childhood Onset Systemic Lupus Erythematosus
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2020
Overall Status: Not yet recruiting
Study Start: October 1, 2020
Primary Completion: September 30, 2025 [Anticipated]
Study Completion: September 30, 2025 [Anticipated]
First Submitted: August 26, 2020
First Submitted that
Met QC Criteria:
August 28, 2020
First Posted: August 31, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
August 28, 2020
Last Update Posted: August 31, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Children's Hospital of Fudan University
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
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.

Open or close this module Conditions
Conditions: Monogenic Lupus
Systemic Lupus Erythematosus
Keywords:
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention: Samples With DNA
Biospecimen 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.
Enrollment: 200 [Anticipated]
Number of Groups/Cohorts 1
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
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.
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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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.
Open or close this module Eligibility
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.
Sampling Method: Probability Sample
Minimum Age:
Maximum Age: 18 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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.
Open or close this module Contacts/Locations
Central Contact Person: Li SUN, PhD
Telephone: 86-21-64932829
Email: lillysun@263.net
Central Contact Backup: Weili YAN, PhD
Telephone: 86-21-64931913
Email: yanwl@fudan.edu.cn
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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