Keloid Tissue Bank - Longitudinal Clinical Data Repository; A Genomic and Molecular Research to Identifying Molecular Markers and Signal Transduction Pathways in Keloid; and Correlations With the Natural History of the Disease.
To aims of this trial are:
1. To prospectively collect keloid and normal skin tissue samples from patients with
keloid by performing keloid tissue biopsy and biopsy of uninvolved skin.
2. To collect blood and/or saliva for genomics, proteomics, tissue culture, flow
cytometery and other keloid investigational studies.
3. To collect any keloid tissue that has been previously removed from the patient
(unrelated to enrollment on this study).
4. To prospectively collect keloid tissue from patients who are undergoing a planned
surgical removal of their keloids.
5. To evaluate keloid histology, genomics, proteomics, molecular markers, cytokines,
growth factors receptors, ligands and signal transduction pathways within keloid tissue
in order to find druggable targets.
6. To prospectively follow the patients and correlate patient demographics and natural
history of the disease, response to the past and future treatments with the genomic and
molecular maker profiles.
7. To culture nucleated blood cells from keloid patients in order to determine the
genomics of this disease as well as learning about potential presence of keloid stem
cell in peripheral blood. To use flow cytometry as well as other technology to search
for circulating keloid stem cells in peripheral blood.
8. To test in vitro:
A- The effect of small molecule kinase inhibitors on the activation of wild-type and mutant
B- The effects of various drugs that inhibit ligands, receptors or pathways.
Observational Model: Case-Only, Time Perspective: Prospective
Percentage of cases with a genetic mutations within the study cohort will be measured.
Prevalence of various biomarkers and/or mutations will be determined and co-related with the clinical presentation of the disease.
Michael H Tirgan, MD
Keloid Research Foundation
United States: Institutional Review Board
|Michael H. Tirgan, MD||New York, New York 10023|