Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Cincinnati, Ohio 45229


Purpose:

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.


Study summary:

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.


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.)


NCT ID:

NCT02511782


Primary Contact:

Principal Investigator
Pooja Khandelwal, MD
Children's Hospital Medical Center, Cincinnati


Backup Contact:

N/A


Location Contact:

Cincinnati, Ohio 45229
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.