Keloid Tissue Bank

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.

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.

Study Overview

• Status: Terminated
• Conditions: Keloid

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
• Enrollment (Actual): 78

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10023
      • Michael H. Tirgan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with keloid; All patients will have a clinical diagnosis of keloid and will consent to participate in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of cases with a genetic mutations within the study cohort will be measured.	Prevalence of various biomarkers and/or mutations will be determined and co-related with the clinical presentation of the disease.	Three years

Collaborators and Investigators

• Sponsor: Tirgan, Michael H., M.D.
• Investigators: Study Chair: Michael H Tirgan, MD, Keloid Research Foundation

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: August 23, 2011
• First Submitted That Met QC Criteria: August 26, 2011
• First Posted (Estimate): August 30, 2011

Study Record Updates

• Last Update Posted (Estimate): November 18, 2014
• Last Update Submitted That Met QC Criteria: November 14, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Keloid
• Additional Relevant MeSH Terms: Pathologic Processes; Connective Tissue Diseases; Fibrosis; Cicatrix; Collagen Diseases; Keloid
• Other Study ID Numbers: Tirgan 11-02