Transdermal Patch to Monitor Inflammatory Biomarkers of GVHD
- Conditions
- Graft Versus Host Disease
- Registration Number
- NCT02511782
- Lead Sponsor
- Children's Hospital Medical Center, Cincinnati
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method CXCL10 in Skin At time of GVHD diagnosis. D-sqaume epidermal discs were used to assess CXCL10 levels from skin.
CXCL10 in Plasma At time of GVHD diagnosis. Plasma was used to assess CXCL10 levels from blood.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Cincinnati Children's Hospital Medical Center🇺🇸Cincinnati, Ohio, United States