Keloid Tissue Bank
|ClinicalTrials.gov Identifier: NCT01425437|
Recruitment Status : Terminated (Poor Enrollment)
First Posted : August 30, 2011
Last Update Posted : November 18, 2014
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||78 participants|
|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.|
|Study Start Date :||June 2012|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||December 2018|
Patients with keloid
All patients will have a clinical diagnosis of keloid and will consent to participate in this study.
- Percentage of cases with a genetic mutations within the study cohort will be measured. [ Time Frame: Three years ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|