Assessment of Serum CD25 Level in Systemic Sclerosis Patients with or Without Interstitial Lung Disease (ILD)

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Assessment of Serum Level of SCD25 in RA, SSc (with or Without ILD) and IPF and Its Correlation with Disease Activity
• Intervention / Treatment: Diagnostic test: blood sampling

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.

• Study Type: Observational
• Enrollment (Estimated): 66

Contacts and Locations

• Study Contact: Name: Esraa Abdelnaser Mostafa Ali, Residant doctor; Phone Number: +201095549467; Email: Esraa.16266318@med.aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

: Systemic sclerosis (SSc) patients with or without ILD.

Description

1. Inclusion criteria:

   SSc patients fulfilled the 2013 ACR/EU LAR criteria (10). Adult age above 18 years.

2. Exclusion criteria:

   • Patients unwilling to participate in the study.
   • Patients with other autoimmune diseases.
   • Patients with interstitial lung disease (ILD) caused by causes other than systemic sclerosis.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy control	Diagnostic test: blood sampling; blood sample to detect sCD25 from systemic sclerosis and Healthy control.
Systemic sclerosis patients	Diagnostic test: blood sampling; blood sample to detect sCD25 from systemic sclerosis and Healthy control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
: Assessment of serum level of sCD25 in SSc (with or without ILD) and its correlation with disease activity.	: Assessment of serum level of sCD25 in SSc (with or without ILD) and its correlation with disease activity.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
. 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).	Baseline

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: September 24, 2024
• First Submitted That Met QC Criteria: September 24, 2024
• First Posted (Actual): September 26, 2024

Study Record Updates

• Last Update Posted (Actual): September 26, 2024
• Last Update Submitted That Met QC Criteria: September 24, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Respiratory Tract Diseases; Connective Tissue Diseases; Lung Diseases; Scleroderma, Systemic; Scleroderma, Diffuse; Lung Diseases, Interstitial
• Other Study ID Numbers: sCd25 in SSC-ILD

Plan for Individual participant data (IPD)

Study Data/Documents

1. Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No