Clinical trial NCT02511782: Transdermal Patch to Monitor Inflammatory Biomarkers of GVHD
Official title: Use of a Transdermal Patch to Noninvasively Monitor Inflammatory Biomarkers of Acute and Chronic Skin GVHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Graft Versus Host Disease
Keywords: children
bone marrow transplant
GVHD
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2015-07-30
Enrollment: 63
Sex: ALL
Minimum age (years): 3
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: CXCL10 in Skin
timeFrame: At time of GVHD diagnosis.
measure: CXCL10 in Plasma
timeFrame: At time of GVHD diagnosis.
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Pooja Khandelwal, MD
role: PRINCIPAL_INVESTIGATOR
References: