NCT06615128

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).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
13mo left

Started Oct 2024

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Oct 2024Jul 2027

First Submitted

Initial submission to the registry

September 24, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

September 26, 2024

Status Verified

September 1, 2024

Enrollment Period

2 years

First QC Date

September 24, 2024

Last Update Submit

September 24, 2024

Conditions

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

Outcome Measures

Primary Outcomes (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.

    Baseline

Secondary Outcomes (1)

  • . Evaluating the clinical correlation of serum soluble CD25 (sCD25) in systemic sclerosis (SSc) (with or without ILD).

    Baseline

Study Arms (2)

Systemic sclerosis patients

Diagnostic Test: blood sampling

Healthy control

Diagnostic Test: blood sampling

Interventions

blood samplingDIAGNOSTIC_TEST

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

Healthy controlSystemic sclerosis patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Esraa Abdelnaser Mostafa Ali, Residant doctor

CONTACT

+201095549467Esraa.16266318@med.aun.edu.eg

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

September 24, 2024

First Posted

September 26, 2024

Study Start

October 1, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

September 26, 2024

Record last verified: 2024-09