Keloid Tissue Bank

Keloid Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01425437
• Other study ID #: Tirgan 11-02
• Status: Terminated
• Phase: N/A
• First received: August 23, 2011
• Last updated: November 14, 2014
• Start date: June 2012
• Est. completion date: December 2018

Study information

• Verified date: November 2014
• Source: Tirgan, Michael H., M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 78
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Keloid

Locations

Country	Name	City	State
United States	Michael H. Tirgan, MD	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Tirgan, Michael H., M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No