Keloid Tissue Bank. A Clinical, Genomic and Molecular Research in Keloid - Full Text View

Sponsor:	Tirgan, Michael H., M.D.
Information provided by (Responsible Party):	Tirgan, Michael H., M.D.
ClinicalTrials.gov Identifier:	NCT01425437

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 Biopsy and 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

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

U.S. FDA Resources

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:

To prospectively collect keloid tissue samples from patients with keloid.
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 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:	18 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 18 years or older.

Criteria

Inclusion Criteria:

Patients must have clinically confirmed diagnosis of keloid
Age of 18 and above
Signed consent form
Able and willing to undergo a keloid biopsy

Exclusion Criteria:

Psychological Illness that may result in non compliance with treatment
Known allergy to lidocaine or other local anesthetics.

Contacts and Locations

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	Not yet 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

St. Luke's-Roosevelt Hospital Center

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:	March 15, 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 May 23, 2012