N/A
N=63
Transdermal Patch to Monitor Inflammatory Biomarkers of GVHD
Graft Versus Host Disease
Bottom Line
View on ClinicalTrials.gov: NCT02511782 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: CXCL10 in Skin — 273; 41; 7.5 Skin CXCL10 femtograms/micrograms — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- D-SQUAME Skin Sampling Discs (Device)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CXCL10 in Skin |
273; 41; 7.5 | <0.01 sig |
| PRIMARY CXCL10 in Plasma |
5198; 608 | <0.01 sig |
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.
Eligibility 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.)
Data sourced from ClinicalTrials.gov (NCT02511782). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.