Clinical Trial: Keloid Tissue Bank

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational

Official Title: Keloid Tissue Bank - Longitudinal Clinical Data Repository; A Genomic and Molecular Research to Identifying Molecular Markers and Signal Transduction Pathways in

Brief Summary: 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.

Detailed Summary:

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 kinases.

B- The effects of various drugs that inhibit ligands, receptors or pathways.


Sponsor: Tirgan, Michael H., M.D.

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Tirgan, Michael H., M.D.

Dates:
Date Received: August 23, 2011
Date Started: June 2012
Date Completion: December 2018
Last Updated: November 14, 2014
Last Verified: November 2014