Transdermal Patch to Monitor Inflammatory Biomarkers of GVHD

NCT02511782 | Completed Results

• 1 other identifier: 2012-0212
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Graft Versus Host Disease

Keywords

children; bone marrow transplant; GVHD

Outcome Measures

Primary Outcomes (2)

• CXCL10 in Skin

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

  At time of GVHD diagnosis.

• CXCL10 in Plasma

  Plasma was used to assess CXCL10 levels from blood.

  At time of GVHD diagnosis.

Study Arms (3)

Acute Graft versus Host Disease

EXPERIMENTAL

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.

Device: D-SQUAME Skin Sampling Discs

Chronic Graft versus Host Disease

EXPERIMENTAL

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.

Device: D-SQUAME Skin Sampling Discs

Healthy Controls

ACTIVE COMPARATOR

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.

Device: D-SQUAME Skin Sampling Discs

Interventions

D-SQUAME Skin Sampling Discs 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.

Acute Graft versus Host Disease; Chronic Graft versus Host Disease; Healthy Controls

Eligibility Criteria

• Age: 3 Months - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Pre-existing skin conditions like, but not limited to epidermolysis bullosa, psoriasis, acne, or cellulitis.
• Bone marrow transplant performed at CCHMC or an outside institution.
• Diagnosis of chronic skin graft versus host disease.
• Bone marrow transplant performed for epidermolysis bullosa.
• Healthy volunteers.
• Age matched to the patients with existing acute skin graft versus host disease.
• Pre-existing dermatologic conditions. (E.g. eczema, psoriasis, acne etc.)

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Results Point of Contact

• Title: Pooja Khandelwal, MD
• Organization: Cincinnati Children's Hospital Medical Center

Pooja.Khandelwal@cchmc.org

513-803-4762

Study Officials

• Pooja Khandelwal, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2015
• First Posted: July 30, 2015
• Study Start: February 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: October 1, 2014
• Last Updated: May 4, 2017
• Results First Posted: May 4, 2017

Record last verified: 2017-03

Locations

US (1)