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

Chronic Graft-versus-host Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02411474
• Other study ID #: 4-2014-0008
• Status: Completed
• Phase: N/A
• First received: March 5, 2015
• Last updated: April 2, 2015
• Start date: March 2014
• Est. completion date: August 2014

Study information

• Verified date: April 2015
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Graft-versus-host Disease
• Graft vs Host Disease

Locations

Country	Name	City	State
Korea, Republic of	Department of Ophthalmology	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Fraser CJ, Bhatia S, Ness K, Carter A, Francisco L, Arora M, Parker P, Forman S, Weisdorf D, Gurney JG, Baker KS. Impact of chronic graft-versus-host disease on the health status of hematopoietic cell transplantation survivors: a report from the Bone Marrow Transplant Survivor Study. Blood. 2006 Oct 15;108(8):2867-73. Epub 2006 Jun 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tear cytokine	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	No
Primary	ocular surface status		3-12 month after SCT	No
Primary	tear film break-up time		3-12 month after SCT	No
Primary	conjunctival injection		3-12 month after SCT	No
Primary	Schirmer's test I		3-12 month after SCT	No
Primary	ocular surface disease index		3-12 month after SCT	No