IgG-4 Levels in Systemic Sclerosis

NCT ID: NCT04219592

Last Updated: 2025-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

154 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-30

Study Completion Date

2024-10-30

Brief Summary

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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.

Detailed Description

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IgG4 levels will be obtained from medical records of 80 SSc patients between the years 2000-2019. These will be compared to IgG4 levels from sera of 80 healthy donors (from Israel blood-bank - MDA). Correlations between IgG4 levels and the following will be made: age, sex, disease type (limited or diffused SSc), disease duration, medications.

Conditions

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Systemic Sclerosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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SSc

74 SSc patients aged 18 - 85

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

Intervention Type DIAGNOSTIC_TEST

IgG4 measurement in mg/dL

Healthy controls

80 Healthy blood-donors aged 18 - 85

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

Intervention Type DIAGNOSTIC_TEST

IgG4 measurement in mg/dL

Interventions

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

IgG4 measurement in mg/dL

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* SSc patients

Exclusion Criteria

* other chronic co-morbidities
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Noa Rabinowicz

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Meir Medical Center

Kfar Saba, , Israel

Site Status

Countries

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Israel

Other Identifiers

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MMC-110-19

Identifier Type: -

Identifier Source: org_study_id

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