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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02411474

Enrollment

Registered

2015-04-08

Start date

2014-03-31

Completion date

2014-08-31

Last updated

2015-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Graft-versus-host Disease

Keywords

stem cell transplantation (SCT)

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
tear film break-up time	3-12 month after SCT	—
conjunctival injection	3-12 month after SCT	—
Schirmer's test I	3-12 month after SCT	—
ocular surface disease index	3-12 month after SCT	—
tear cytokine	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
ocular surface status	3-12 month after SCT	—

Countries

South Korea

Outcome results