Keloid Tissue Bank
Much progress in treatment of various tumors has been made in the laboratory and the results have been brought back to the patients, i.e. from bench to bedside. This trial intends to collect samples of keloid tissue from patients and study them in laboratory. Such a research may help us with finding better treatments for keloid.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||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.|
- Percentage of cases with a genetic mutations within the study cohort will be measured. [ Time Frame: Three years ] [ Designated as safety issue: No ]Prevalence of various biomarkers and/or mutations will be determined and co-related with the clinical presentation of the disease.
Biospecimen Retention: Samples With DNA
Sample of keloid tissue and small amount of normal appearing skin from an area that is adjacent to the keloid will be collected from each participant. Each patient may undergo one or more biopsies during the span of this study. Tissue biopsy may be repeated from the same or a different keloid in the same patient. Patients may be re-contacted for additional blood or other tissue samples.
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||June 2018 (Final data collection date for primary outcome measure)|
Patients with keloid
All patients will have a clinical diagnosis of keloid and will consent to participate in this study.
To aims of this trial are:
- To prospectively collect keloid and normal skin tissue samples from patients with keloid by performing keloid tissue biopsy and biopsy of uninvolved skin.
- To collect blood and/or saliva for genomics, proteomics, tissue culture, flow cytometery and other keloid investigational studies.
- To collect any keloid tissue that has been previously removed from the patient (unrelated to enrollment on this study).
- To prospectively collect keloid tissue from patients who are undergoing a planned surgical removal of their keloids.
- 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.
- 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.
- 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.
- To test in vitro:
A- The effect of small molecule kinase inhibitors on the activation of wild-type and mutant kinases.
B- The effects of various drugs that inhibit ligands, receptors or pathways.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01425437
|United States, New York|
|Michael H. Tirgan, MD|
|New York, New York, United States, 10023|
|Study Chair:||Michael H Tirgan, MD||Keloid Research Foundation|