Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06615128
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
Assessment of Serum CD25 Level in Systemic Sclerosis Patients with or Without Interstitial Lung Disease ILD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Assessment of Serum CD25 Level in Systemic Sclerosis Patients with or Without Interstitial Lung Disease ILD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Assessment of serum level of sCD25 in SSc with or without ILD and its correlation with disease activity
Evaluating the clinical correlation of serum soluble CD25 sCD25 in systemic sclerosis SSc with or without ILD
Evaluating the clinical correlation of serum soluble CD25 sCD25 in systemic sclerosis SSc with or without ILD
Detailed Description:
Interstitial lung disease ILD comprises of a large group of idiopathic diffuse processes that affect the lung parenchyma Connective tissue disease-associated lung disease CTD-ILD represents one of the most common causes of ILD Along with idiopathic pulmonary fibrosis IPF they both represent the majority of ILDs Since CTD-ILD typically follows a better clinical course compared to IPF and hence therapies differ substantially between them an accurate diagnosis is critical Up to 30 of newly diagnosed ILD will be due to CTD This underscores the importance of investigating all patients with ILD for possible underlying CTD
Systemic sclerosis SSc is a systemic autoimmune disease in which inflammation and fibrosis play a crucial role and lead to severe damage and failure of multiple organs such as the skin joints tendons gastrointestinal tract lungs heart blood vessels and kidneys In SSc the presence of ILD is even more common 80 in addition pulmonary hypertension PH also in the absence of diffuse lung disease can be demonstrated by cardiac catheterisation in 10 of cases These conditions are the two main prognostic factors for SSc patients in fact 40 of deaths in SSc are attributable to pulmonary pathology 4
CD25 the IL-2 receptor α chain is one subunit of the high-affinity IL-2 receptor IL2R which is comprised of IL2R alpha CD25 beta CD122 and the common gamma chain CD132 It is well known that soluble CD25 sCD25 is generated as a consequence of proteolytic cleavage mainly from the membrane of activated T cells and the serum concentrations of sCD25 are associated with the proliferation of activated T cells High serum sCD25 levels have been reported in patients with various autoimmune diseases Previous studies have shown that sCD25 can act as an early inhibitor of T-cell response related to IL-2 signalling In the experimental autoimmune encephalomyelitis EAE model sCD25 can enhance the Th17 response and exacerbate EAE by prohibiting signalling by sequestering the local IL-2 and IL-2R interaction sCD25 can efficiently bind to secreted IL-2 suggesting its ability to serve as a decoy receptor for IL-2 to play a pathogenic role in autoimmunity development
Systemic sclerosis SSc is a systemic autoimmune disease in which inflammation and fibrosis play a crucial role and lead to severe damage and failure of multiple organs such as the skin joints tendons gastrointestinal tract lungs heart blood vessels and kidneys In SSc the presence of ILD is even more common 80 in addition pulmonary hypertension PH also in the absence of diffuse lung disease can be demonstrated by cardiac catheterisation in 10 of cases These conditions are the two main prognostic factors for SSc patients in fact 40 of deaths in SSc are attributable to pulmonary pathology 4
CD25 the IL-2 receptor α chain is one subunit of the high-affinity IL-2 receptor IL2R which is comprised of IL2R alpha CD25 beta CD122 and the common gamma chain CD132 It is well known that soluble CD25 sCD25 is generated as a consequence of proteolytic cleavage mainly from the membrane of activated T cells and the serum concentrations of sCD25 are associated with the proliferation of activated T cells High serum sCD25 levels have been reported in patients with various autoimmune diseases Previous studies have shown that sCD25 can act as an early inhibitor of T-cell response related to IL-2 signalling In the experimental autoimmune encephalomyelitis EAE model sCD25 can enhance the Th17 response and exacerbate EAE by prohibiting signalling by sequestering the local IL-2 and IL-2R interaction sCD25 can efficiently bind to secreted IL-2 suggesting its ability to serve as a decoy receptor for IL-2 to play a pathogenic role in autoimmunity development
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None