IgG-4 Levels in Systemic Sclerosis (SSc-IgG4)

January 7, 2020 updated by: Noa Rabinowicz, Meir Medical Center

Comparing IgG-4 Levels in Systemic Sclerosis Patients vs. Healthy Controls

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

154

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Kfar Saba, Israel
        • Meir Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Medical records of SSc patients from Meir Medical Center

Description

Inclusion Criteria:

  • SSc patients

Exclusion Criteria:

  • other chronic co-morbidities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SSc
74 SSc patients aged 18 - 85
Diagnostic test: IgG4 measurement (non-interventional, just obtaining data from medical records)
IgG4 measurement in mg/dL
Healthy controls
80 Healthy blood-donors aged 18 - 85
Diagnostic test: IgG4 measurement (non-interventional, just obtaining data from medical records)
IgG4 measurement in mg/dL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IgG4 measurement
Time Frame: 4 months
quantifying IgG4 in each group and in SSc subgroups based on disease type, organs involved, medications.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2019

Primary Completion (Actual)

September 30, 2019

Study Completion (Anticipated)

February 28, 2020

Study Registration Dates

First Submitted

January 5, 2020

First Submitted That Met QC Criteria

January 5, 2020

First Posted (Actual)

January 7, 2020

Study Record Updates

Last Update Posted (Actual)

January 10, 2020

Last Update Submitted That Met QC Criteria

January 7, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMC-110-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

not relevant

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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