Keloid Tissue Bank

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01425437
Recruitment Status : Terminated (Poor Enrollment)
First Posted : August 30, 2011
Last Update Posted : November 18, 2014
Information provided by (Responsible Party):
Tirgan, Michael H., M.D.

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.

Condition or disease

Detailed Description:

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.

Study Type : Observational
Actual Enrollment : 78 participants
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.
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.

Primary Outcome Measures :
  1. 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
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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with a clinical diagnosis of keloid who are 13 years or older.

Inclusion Criteria:

  1. Patients must have clinically confirmed diagnosis of keloid
  2. Signed consent form; parent or a legal guardian should consent for children and those under age of 18.
  3. Have at least one paraffin block of excess keloid tissue that has been removed in the past; or is planned to be removed in future.
  4. Able and willing to undergo a keloid biopsy (optional)
  5. Able and willing to undergo biopsy of their normal appearing skin (optional, minimum age 18).

Exclusion Criteria:

  1. Individuals who are mentally challenged, who cannot consent to participate in this study.
  2. Psychological Illness that may result in non-compliance with the procedure and the required follow up.
  3. Known allergy to lidocaine or other local anesthetics.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01425437

United States, New York
Michael H. Tirgan, MD
New York, New York, United States, 10023
Sponsors and Collaborators
Tirgan, Michael H., M.D.
Study Chair: Michael H Tirgan, MD Keloid Research Foundation

Responsible Party: Tirgan, Michael H., M.D. Identifier: NCT01425437     History of Changes
Other Study ID Numbers: Tirgan 11-02
First Posted: August 30, 2011    Key Record Dates
Last Update Posted: November 18, 2014
Last Verified: November 2014

Keywords provided by Tirgan, Michael H., M.D.:

Additional relevant MeSH terms:
Collagen Diseases
Connective Tissue Diseases
Pathologic Processes