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Role of Metabolic Enzymes in Non-Melanoma Skin Cancer

This study has been completed.
Sponsor:
Collaborators:
Chao Family Comprehensive Cancer Center
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT02244749
First received: September 10, 2014
Last updated: February 8, 2017
Last verified: February 2017
  Purpose
The researcher can proved that certain compounds play an important role in the prevention of skin cancer. Researcher can use specific compounds, which classified as metabolic enzymes, and lower concentrations and complete absent in skin cancer cells. Researcher can biopsies of normal skin and precancerous or cancerous lesions, and can compare the concentrations of these compounds to determine the difference between the two areas. The result can lead to further understanding of skin cancers and pre-cancers. Because skin cancers and pre-cancers are so common, any knowledge would be very useful for many people in the future and may be used for development of future treatments or prevention strategies.

Condition Intervention
Skin Cancer Other: skin specimen

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Role of Metabolic Enzymes in Non-Melanoma Skin Cancer: Potential for Informative Biomarkers and Therapeutic Targets

Resource links provided by NLM:


Further study details as provided by Beckman Laser Institute and Medical Center, University of California, Irvine:

Primary Outcome Measures:
  • expression levels of metabolic enzymes in normal skin versus precancerous lesions or skin cancer [ Time Frame: 1 month ]

    Overall, compare normal skin versus precancerous lesions or skin cancer from the same individual. Paired tests of samples are selected from the same subjects.

    • 10 actinic keratosis samples,
    • 10 basal cell carcinoma samples
    • 20 squamous cell carcinoma samples
    • Normal skin control biopsy from the same subject will be collected.


Enrollment: 26
Study Start Date: March 2011
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
skin specimen
skin specimen
Other: skin specimen
skin specimen

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Study population will be selected from University of California Irvine Medical Cencal
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02244749

Locations
United States, California
Beckman Laser Institute
Irvine, California, United States, 92612
Gottschalk Medical Plaza, 1 Medical Plaza Drive
Irvine, California, United States, 92697
Sponsors and Collaborators
University of California, Irvine
Chao Family Comprehensive Cancer Center
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: Kristen Kelly, MD Beckman Laser Institute, UCI
  More Information

Responsible Party: Beckman Laser Institute and Medical Center, Kirsten Kelly, M.D., Professor of Dermatology and Surgery, University of California, Irvine
ClinicalTrials.gov Identifier: NCT02244749     History of Changes
Other Study ID Numbers: NIH/LAMMP-2010-7851
SEED Grant 405181-66496 ( Other Identifier: NCI )
Study First Received: September 10, 2014
Last Updated: February 8, 2017

Additional relevant MeSH terms:
Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases

ClinicalTrials.gov processed this record on June 23, 2017