Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06412614
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-05-06
Brief Title:
Evaluation of Patients With Systemic Sclerosis Without Specific or Associated Autoantibodies
Sponsor:
Central Hospital Nancy France
Organization:
Central Hospital Nancy France
Study Overview
Official Title:
Phenotypic Evaluation of Patients With Systemic Sclerosis Without Specific or Associated Autoantibodies
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
SCLERONAB
Brief Summary:
Systemic sclerosis SSc is a complex systemic autoimmune disease with variable phenotype and prognosis Autoantibodies are important diagnostic biomarkers in SSc More than 90 of patients with SSc had anti-nuclear antibodies Autoantibodies specific to SSc anti-topoisomerase I antibodies anti-centromeres anti-RNA polymerase III anti-ThTo anti-fibrillarin anti-NOR90 or associated with overlap syndromes anti-RNA polymerase III antibodies -PMScl anti-KU anti-U1RNP anti-TRIM21 are detected in most patients Excluding anti-TRIM21 antibodies autoantibodies are usually mutually exclusive and are associated with distinct phenotypes
Around 5 to 10 of patients with SSc have no autoantibodies detectable with routine biological tests Recently new autoantibody specificities have been described in SSc anti-eIF2B anti-RuvBL12 anti-BICD2 anti-U11U12 RNP antibodies
Seronegative patients could represent new specificities of autoantibodies unknown or not currently routinely evaluated associated with different phenotypes of the disease
Primary objective is to compare the phenotype of patients with systemic sclerosis with or without detectable specific or associated autoantibodies
Secondary objectives are
to determine homogeneous groups of patients with systemic sclerosis without detectable specific or associated autoantibodies
to compare the phenotype of patients with systemic sclerosis without detectable specific or associated autoantibodies according to anti-nuclear antibodies status
Around 5 to 10 of patients with SSc have no autoantibodies detectable with routine biological tests Recently new autoantibody specificities have been described in SSc anti-eIF2B anti-RuvBL12 anti-BICD2 anti-U11U12 RNP antibodies
Seronegative patients could represent new specificities of autoantibodies unknown or not currently routinely evaluated associated with different phenotypes of the disease
Primary objective is to compare the phenotype of patients with systemic sclerosis with or without detectable specific or associated autoantibodies
Secondary objectives are
to determine homogeneous groups of patients with systemic sclerosis without detectable specific or associated autoantibodies
to compare the phenotype of patients with systemic sclerosis without detectable specific or associated autoantibodies according to anti-nuclear antibodies status
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