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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.


N/A
13 Years
N/A
Open (Enrolling)
Both
Keloid

Thank you

Trial Information

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.


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Percentage of cases with a genetic mutations within the study cohort will be measured.

Outcome Description:

Prevalence of various biomarkers and/or mutations will be determined and co-related with the clinical presentation of the disease.

Outcome Time Frame:

Three years

Safety Issue:

No

Principal Investigator

Michael H Tirgan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Keloid Research Foundation

Authority:

United States: Institutional Review Board

Study ID:

Tirgan 11-02

NCT ID:

NCT01425437

Start Date:

June 2012

Completion Date:

December 2014

Related Keywords:

  • Keloid
  • Keloid
  • Keloid

Name

Location

Michael H. Tirgan, MDNew York, New York  10023