Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04534647
Status:
RECRUITING
Last Update Posted:
2021-04-26
First Post:
2020-08-24
Brief Title:
Serological and Urinary Biomarkers in Latin American Patients With Systemic Lupus Erythematosus GLADEL 20 Cohort
Sponsor:
Liga Panamericana de Asociaciones de Reumatologia PANLAR
Organization:
Liga Panamericana de Asociaciones de Reumatologia PANLAR
Study Overview
Official Title:
Serological and Urinary Biomarkers in Latin American Patients With Systemic Lupus Erythematosus GLADEL 20 Cohort
Status:
RECRUITING
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Lupus nephritis LN is one of the main manifestationsin SLE patients having an important impact on morbidity and mortality Renal biopsy is the gold standard for the diagnosis of LN however it is an invasive technique not free of complicationswhich is not recommended to be performed serially as a follow-up tool for patients with LN Searching for biomarkers in SLE has been the subject of interesting research although results have not always been relevant Multiple biomarkers have been studied in different locations soluble markers in blood urine and biological fluidsof different natureautoantibodies genetic markers of kidney damage looking atdiagnostic andorprognostic features In recent years several biomarkers have been developed that seek to find an association with pathological patterns with pathogenic mechanisms and with a non-invasive diagnosis of different glomerulopathies allowing the identification of prognostic subgroups in each type of kidney disease while predicting response to treatment andor recurrence To date double-stranded anti-DNA antibodies anti-dsDNA and serum complement are the only non-invasive routine biomarkers for monitoring renal activity in patients with LN However these markers are only the reflection of the immune activity of the disease and they are not markers of renal damage or poor prognosis For all the above the purpose of this study is in a case-control study to evaluate simultaneously serum ANA anti-dsDNA anti-C1q anti-cardiolipin IgG and IgM anti-ß2GPI IgG and IgM anti-phosphatidylserineprothrombin antibodies and anti-DFS70 antibodies and urinary biomarkers and the presence of anti-DFS70 antibodies in a multiethnic cohort of patients with SLE such as the cohort of GLADEL and assess its possible correlation with various socio-demographic clinical and serological manifestations of the disease
In subgroup of patients transcriptome studies will be performed using RNA from blood and tissue to identify possible transcriptional signatures
In subgroup of patients transcriptome studies will be performed using RNA from blood and tissue to identify possible transcriptional signatures
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None