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Clinical Trials/NCT02511782
NCT02511782
Completed
Not Applicable

Use of a Transdermal Patch to Noninvasively Monitor Inflammatory Biomarkers of Acute and Chronic Skin GVHD

Children's Hospital Medical Center, Cincinnati1 site in 1 country63 target enrollmentFebruary 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Graft Versus Host Disease
Sponsor
Children's Hospital Medical Center, Cincinnati
Enrollment
63
Locations
1
Primary Endpoint
CXCL10 in Skin
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The aim of this study is to measure local inflammatory responses in patients undergoing an allogeneic stem cell transplant and attempt to define any set of biomarkers that are significantly altered in acute or chronic skin graft versus host disease.

Detailed Description

Acute skin graft versus host disease is a significant complication following allogeneic stem cell transplant. To date, there are no specific dermal biomarkers that predict or define the onset of acute skin graft versus host disease. The primary objective of this study is to observe the changes in the inflammatory environment of the skin during the process of acute and chronic skin graft versus host disease. This will be accomplished by using a non-invasive transdermal patch called D-Squame to analyze inflammatory cytokines and key epidermal proteins. Patients will be enrolled prior to receiving a stem cell transplant and followed weekly after stem cell infusion until day 99. If acute skin graft versus host disease develops, they will be followed weekly until resolution of acute graft versus host disease or development of chronic graft versus host disease, whichever occurs first. Patients with a diagnosis of chronic skin graft versus host disease will be enrolled and followed weekly until 4 weeks, irrespective of clinical course. In addition, healthy controls will be enrolled and used as comparators. The relevance of this study is to provide a better understanding of the local inflammatory environment induced by acute or chronic skin graft versus host disease. This is likely to enable the investigators to define a biomarker panel that predicts the onset of acute graft versus host disease rapidly and non-invasively.

Registry
clinicaltrials.gov
Start Date
February 2012
End Date
October 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

CXCL10 in Skin

Time Frame: At time of GVHD diagnosis.

D-sqaume epidermal discs were used to assess CXCL10 levels from skin.

CXCL10 in Plasma

Time Frame: At time of GVHD diagnosis.

Plasma was used to assess CXCL10 levels from blood.

Study Sites (1)

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