Trial Outcomes & Findings for Transdermal Patch to Monitor Inflammatory Biomarkers of GVHD (NCT NCT02511782)
NCT ID: NCT02511782
Last Updated: 2017-05-04
Results Overview
D-sqaume epidermal discs were used to assess CXCL10 levels from skin.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
63 participants
Primary outcome timeframe
At time of GVHD diagnosis.
Results posted on
2017-05-04
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
51
|
2
|
10
|
|
Overall Study
COMPLETED
|
50
|
2
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
Transdermal Patch to Monitor Inflammatory Biomarkers of GVHD
Baseline characteristics by cohort
| Measure |
Acute Graft Versus Host Disease
n=51 Participants
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.
|
Chronic Graft Versus Host Disease
n=2 Participants
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.
|
Healthy Controls
n=10 Participants
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.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
51 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At time of GVHD diagnosis.Population: We did not analyze all acute GVHD samples for financial reasons.
D-sqaume epidermal discs were used to assess CXCL10 levels from skin.
Outcome measures
| Measure |
Acute Graft Versus Host Disease
n=20 Participants
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.
|
Healthy Controls
n=10 Participants
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.
|
Chronic Graft Versus Host Disease
n=2 Participants
This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop chronic graft versus host disease.
|
|---|---|---|---|
|
CXCL10 in Skin
|
273 Skin CXCL10 femtograms/micrograms
Standard Error 95
|
41 Skin CXCL10 femtograms/micrograms
Standard Error 76
|
7.5 Skin CXCL10 femtograms/micrograms
Standard Error 2.11
|
PRIMARY outcome
Timeframe: 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.
Plasma was used to assess CXCL10 levels from blood.
Outcome measures
| Measure |
Acute Graft Versus Host Disease
n=20 Participants
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.
|
Healthy Controls
n=10 Participants
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.
|
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.
|
|---|---|---|---|
|
CXCL10 in Plasma
|
5198 Plasma CXCL10 picograms/microliters
Standard Error 943
|
608 Plasma CXCL10 picograms/microliters
Standard Error 302
|
—
|
Adverse Events
Acute Graft Versus Host Disease
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Chronic Graft Versus Host Disease
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Pooja Khandelwal, MD
Cincinnati Children's Hospital Medical Center
Phone: 513-803-4762
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place