- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02244749
Role of Metabolic Enzymes in Non-Melanoma Skin Cancer
Role of Metabolic Enzymes in Non-Melanoma Skin Cancer: Potential for Informative Biomarkers and Therapeutic Targets
Study Overview
Detailed Description
Biopsy procedure will be done at the Beckman Laser Institute or at the Dermatology Clinic Gottschalk Medical Plaza, of University of California, Irvine. Standard procedure of punch biopsy will be done in the areas determined by the physician researchers. The normal skin biopsy will be obtained from an area of skin without any suspicious lesions located on an area of the body. Biopsy specimens will be stored frozen at Beckman Laser Institute chemistry-lab for research and will be assigned with subject ID number, there will be no personnel health information attach to the skin specimens. There will be no cost to the subject or their insurer for participation in this study, except in the specific scenario of a suspected skin cancer that would undergo biopsy regardless of participation in this study. The time commitment for each subject is approximately 1 hour for each set of biopsies.
Researchers can test the hypothesis that expression of key metabolic enzymes is reduced and/or lost during skin cancer progression. Total ribonucleic acid, a single-stranded biologic molecule involved in gene transcription, regulation, and translation, can be isolated from biopsied skin specimens. Quantitative Real-Time can be performed to determine the expression levels of several key metabolic enzymes.
Metabolic enzymes regulate several vital signaling pathways in the human body. Some examples include hormone and bioactive lipid regulation. Aberrant regulation of these signaling pathways can lead to human diseases including cancer.
Recent evidence has shown that metabolic enzyme call UGT in the genes call UDP-glucuronosyltransferases were shown to have significantly reduced expression in breast tumors compared with normal breast tissue from the same patients This observed loss of expression is hypothesized to be causal as these two enzymes are responsible for estrogen metabolism.
However, relatively little is known about metabolic enzymes and skin cancer. We have preliminary data that UGT enzyme expression is lost during melanoma progression which allows deregulated lipoxygenase signaling.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Irvine, California, United States, 92612
- Beckman Laser Institute
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Irvine, California, United States, 92697
- Gottschalk Medical Plaza, 1 Medical Plaza Drive
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male or Female are age18 years and older
- Have normal skin and a skin lesion of interest
- Willing to have skin biopsies on those areas
Exclusion Criteria:
- Male or Female are under 18 years of age
- Pregnant women
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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skin specimen
|
skin specimen
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
expression levels of metabolic enzymes in normal skin versus precancerous lesions or skin cancer
Time Frame: 1 month
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Overall, compare normal skin versus precancerous lesions or skin cancer from the same individual. Paired tests of samples are selected from the same subjects.
|
1 month
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20107851
- SEED Grant 405181-66496 (Other Identifier: NCI)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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