Transdermal Patch to Monitor Inflammatory Biomarkers of GVHD

NCT ID: NCT02511782

Last Updated: 2017-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-10-31

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.

Conditions

Graft Versus Host Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Acute Graft versus Host Disease

This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop acute graft versus host disease. Skin cell samples will be collected using the D-SQUAME Skin Sampling Discs. The first baseline skin sample will be obtained prior to the preparative regimen for stem cell transplant. Samples will be collected weekly after stem cell infusion until 8 weeks, if acute GVHD does not develop. If acute GVHD does develop, weekly samples will continue to be collected until resolution of acute GVHD or development of chronic GVHD, whichever occurs first. Blood samples will be collected at these same time points.

Group Type: EXPERIMENTAL

D-SQUAME Skin Sampling Discs

Intervention Type: DEVICE

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.

Chronic Graft versus Host Disease

This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop chronic graft versus host disease. Skin cell samples will be collected weekly for 4 weeks using the D-SQUAME Skin Sampling Discs. Blood samples will be collected at these same time points.

Group Type: EXPERIMENTAL

D-SQUAME Skin Sampling Discs

Intervention Type: DEVICE

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.

Healthy Controls

This study arm includes healthy age matched controls as comparisons to study participants who develop graft versus host disease. These controls may be either healthy age matched siblings of patients who develop acute graft versus host disease or healthy age matched siblings of patients that are seen in the bone marrow transplant, oncology, or hematology clinics. A one-time single skin cell sample will be collected using a D-SQUAME Skin Sampling Disc. Blood samples will not be collected from the healthy controls.

Group Type: ACTIVE_COMPARATOR

D-SQUAME Skin Sampling Discs

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• All patients undergoing an allogeneic hematopoietic stem cell transplant at CCHMC.
• All conditioning regimens are eligible.

• Bone marrow transplant performed at CCHMC or an outside institution.
• Diagnosis of chronic skin graft versus host disease.

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

Exclusion Criteria

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

• Bone marrow transplant performed for epidermolysis bullosa.

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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pooja Khandelwal, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

2012-0212

Identifier Type: -

Identifier Source: org_study_id