Tear Cytokine Analysis as a Prediction or Diagnostic Marker in Ocular GvHD

April 2, 2015 updated by: Yonsei University
Investigate the profiles of tear cytokines in patients who underwent stem cell transplantation (SCT) and attempted to determine the applicability of tear cytokines in the diagnosis of chronic graft-versus-host disease (GVHD). Evaluate tear cytokines as biomarkers of chronic ocular GVHD severity.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

21

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

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

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Male or non-pregnant female patients aged 20-60 years who visited the clinic 3-12 months after SCT were included in the study.

Description

Inclusion Criteria:

  • The patients patients aged 20-60 years who visited the clinic 3-12 months after SCT were included in the study.

Exclusion Criteria:

  • The patients with histories of ocular surgery; ocular injury; and ocular diseases such as ocular infection, allergy, and autoimmune disease, as well as patients with long-term use of topical ocular medications except artificial tears.

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
With or without newly diagnosed chronic GVHD after SCT
The patients developed chronic GVHD after SCT/ The patients did not developed chronic GVHD after SCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tear cytokine
Time Frame: 3-12 month after SCT
comparison of tear cytokines (IL-2,4,10,17a, INF-r, TNF-a) concentrations in patients with or without newly diagnosed chronic GVHD after SCT using a multiplex immunobead assay
3-12 month after SCT
ocular surface status
Time Frame: 3-12 month after SCT
3-12 month after SCT
tear film break-up time
Time Frame: 3-12 month after SCT
3-12 month after SCT
conjunctival injection
Time Frame: 3-12 month after SCT
3-12 month after SCT
Schirmer's test I
Time Frame: 3-12 month after SCT
3-12 month after SCT
ocular surface disease index
Time Frame: 3-12 month after SCT
3-12 month after SCT

Collaborators and Investigators

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

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2014

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

March 5, 2015

First Submitted That Met QC Criteria

April 2, 2015

First Posted (Estimate)

April 8, 2015

Study Record Updates

Last Update Posted (Estimate)

April 8, 2015

Last Update Submitted That Met QC Criteria

April 2, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2014-0008

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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