Graft Versus Host Disease
Conditions
Keywords
children, bone marrow transplant, GVHD
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.
Interventions
DEVICED-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.
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 30 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CXCL10 in Skin | At time of GVHD diagnosis. | D-sqaume epidermal discs were used to assess CXCL10 levels from skin. |
| CXCL10 in Plasma | At time of GVHD diagnosis. | Plasma was used to assess CXCL10 levels from blood. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 51 |
| 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.
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. | 2 |
| 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.
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. | 10 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Acute Graft Versus Host Disease | Chronic Graft Versus Host Disease | Healthy Controls | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 51 Participants | 2 Participants | 10 Participants | 63 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 16 Participants | 0 Participants | 5 Participants | 21 Participants |
| Sex: Female, Male Male | 35 Participants | 2 Participants | 5 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 51 | 0 / 2 | 0 / 10 |
| serious Total, serious adverse events | 0 / 51 | 0 / 2 | 0 / 10 |
Outcome results
Primary
CXCL10 in Plasma
Plasma was used to assess CXCL10 levels from blood.
Time frame: At time of GVHD diagnosis.
Population: We did not analyze the plasma collected from patients with chronic skin GVHD; therefore, there is no data to report. We did not analyze all acute GVHD samples for financial reasons.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acute Graft Versus Host Disease | CXCL10 in Plasma | 5198 Plasma CXCL10 picograms/microliters | Standard Error 943 |
| Healthy Controls | CXCL10 in Plasma | 608 Plasma CXCL10 picograms/microliters | Standard Error 302 |
p-value: <0.01t-test, 2 sided
Primary
CXCL10 in Skin
D-sqaume epidermal discs were used to assess CXCL10 levels from skin.
Time frame: At time of GVHD diagnosis.
Population: We did not analyze all acute GVHD samples for financial reasons.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acute Graft Versus Host Disease | CXCL10 in Skin | 273 Skin CXCL10 femtograms/micrograms | Standard Error 95 |
| Healthy Controls | CXCL10 in Skin | 41 Skin CXCL10 femtograms/micrograms | Standard Error 76 |
| Chronic Graft Versus Host Disease | CXCL10 in Skin | 7.5 Skin CXCL10 femtograms/micrograms | Standard Error 2.11 |
p-value: <0.01t-test, 2 sided