Keloid Tissue Bank

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by Tirgan, Michael H., M.D.
Sponsor:
Information provided by (Responsible Party):
Tirgan, Michael H., M.D.
ClinicalTrials.gov Identifier:
NCT01425437
First received: August 23, 2011
Last updated: June 9, 2012
Last verified: June 2012
  Purpose

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
Keloid

Study Type: Observational
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.

Further study details as provided by Tirgan, Michael H., M.D.:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with keloid
All patients will have a clinical diagnosis of keloid and will consent to participate in this study.

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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient with a clinical diagnosis of keloid who are 13 years or older.

Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01425437

Contacts
Contact: Michael H Tirgan, MD (212) 874 4200 htirgan@aol.com

Locations
United States, New York
Michael H. Tirgan, MD Recruiting
New York, New York, United States, 10023
Contact: Michael H. Tirgan, MD    212-874-4200    htirgan@aol.com   
Principal Investigator: Michael H. Tirgan, MD         
Sponsors and Collaborators
Tirgan, Michael H., M.D.
Investigators
Study Chair: Michael H Tirgan, MD Keloid Research Foundation
  More Information

No publications provided

Responsible Party: Tirgan, Michael H., M.D.
ClinicalTrials.gov Identifier: NCT01425437     History of Changes
Other Study ID Numbers: Tirgan 11-02
Study First Received: August 23, 2011
Last Updated: June 9, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Keloid
Collagen Diseases
Connective Tissue Diseases
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on August 19, 2014