Keloid Tissue Bank

Terminated

• Conditions: Keloid

• Registration Number: NCT01425437
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2011-08-23
• Study First Submitted QC: 2011-08-26
• Study First Posted: 2011-08-30
• Study Start: 2012-06
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-14
• Last Update Posted: 2014-11-18
• Primary Completion: 2018-06
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 78

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Michael H. Tirgan, MD; 🇺🇸 New York, New York, United States