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Assessment of Serum Level of SCD25 in RA, SSc (with or Without ILD) and IPF and Its Correlation with Disease ActivityNCT06615128

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

An observational study of Assessment of Serum Level of SCD25 in RA, SSc (with or Without ILD) and IPF and Its Correlation with Disease Activity, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
blood sampling
How many people
66 participants
Where
No sites listed yet
Study dates
1 Oct 2024to 1 Jul 2027
How long will I take part?
3 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

  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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Esraa Abdelnaser Mostafa Ali, Residant doctor contact

+201095549467

Esraa.16266318@med.aun.edu.eg

About this study

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).

Read the 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.

Being tested
blood sampling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • blood samplingDiagnostic test

    blood sample to detect sCD25 from systemic sclerosis and Healthy control.

Study groups in NCT06615128
Study groupRoleWhat they receive
Systemic sclerosis patientsNot described
Receives: Diagnostic Test: blood sampling
Healthy controlNot described
Receives: Diagnostic Test: blood sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. : 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.

    Measured: Baseline

Secondary outcomes (1)
  1. . 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).

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2024
  2. Study start1 Oct 2024 (estimated)
  3. Primary completion1 Oct 2026 (estimated)
  4. Study completion1 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
66 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06615128
Sponsor's protocol ID
sCd25 in SSC-ILD
Status last verified
Sep 2024
First submitted
24 Sep 2024
Last updated
26 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Assessment of Serum Level of SCD25 in RA, SSc (with or Without ILD) and IPF and Its Correlation with Disease Activity, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Esraa Abdelnaser Mostafa Ali, Residant doctor (+201095549467, Esraa.16266318@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

: Assessment of serum level of sCD25 in SSc (with or without ILD) and its correlation with disease activity. (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.

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