NCT04219592

Brief Summary

This is an observational - non interventional study. The investigators will compare IgG4 levels of 80 healthy donors (from Israel blood bank - MDA) and 80 Systemic Sclerosis patients from Meir Medical Center.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
154

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

May 30, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2020

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

5.3 years

First QC Date

January 5, 2020

Last Update Submit

May 13, 2025

Conditions

Systemic Sclerosis

Keywords

SScIgG4

Outcome Measures

Primary Outcomes (1)

  • IgG4 measurement

    quantifying IgG4 in each group and in SSc subgroups based on disease type, organs involved, medications.

    4 months

Study Arms (2)

SSc

74 SSc patients aged 18 - 85

Diagnostic Test: IgG4 measurement (non-interventional, just obtaining data from medical records)

Healthy controls

80 Healthy blood-donors aged 18 - 85

Diagnostic Test: IgG4 measurement (non-interventional, just obtaining data from medical records)

Interventions

IgG4 measurement (non-interventional, just obtaining data from medical records)DIAGNOSTIC_TEST

IgG4 measurement in mg/dL

Healthy controlsSSc

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Medical records of SSc patients from Meir Medical Center

You may qualify if:

  • SSc patients

You may not qualify if:

  • other chronic co-morbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

sera from healthy participants purchased from MDA will be used as control.

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 5, 2020

First Posted

January 7, 2020

Study Start

May 30, 2019

Primary Completion

September 30, 2024

Study Completion

October 30, 2024

Last Updated

May 16, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

not relevant

Locations

IL(1)