Transdermal Patch to Monitor Inflammatory Biomarkers of GVHD

Graft Versus Host Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02511782
• Other study ID #: 2012-0212
• Status: Completed
• Phase: N/A
• First received: June 10, 2015
• Last updated: January 28, 2016
• Start date: February 2012
• Est. completion date: October 2014

Study information

• Verified date: January 2016
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: October 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Months to 30 Years

Eligibility

Inclusion criteria for patients who may develop acute graft versus host disease:

• All patients undergoing an allogeneic hematopoietic stem cell transplant at CCHMC.

• All conditioning regimens are eligible.

Exclusion criteria for patients who may develop acute graft versus host disease:

• Pre-existing skin conditions like, but not limited to epidermolysis bullosa, psoriasis, acne, or cellulitis.

Inclusion criteria for patients who have chronic graft versus host disease:

• Bone marrow transplant performed at CCHMC or an outside institution.

• Diagnosis of chronic skin graft versus host disease.

Exclusion criteria for patients who have chronic graft versus host disease:

• Bone marrow transplant performed for epidermolysis bullosa.

Inclusion criteria for controls:

• Healthy volunteers.

• Age matched to the patients with existing acute skin graft versus host disease.

Exclusion criteria for controls:

• Pre-existing dermatologic conditions. (E.g. eczema, psoriasis, acne etc.)

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Graft Versus Host Disease
• Graft vs Host Disease

Intervention

Device:
• D-SQUAME Skin Sampling Discs
A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory Change in the Skin	D-SQUAME discs will be used for analysis.	Change from baseline to 99 days after stem cell infusion.	No