NCT02244749

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2011

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 19, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

4.4 years

First QC Date

September 10, 2014

Last Update Submit

October 28, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • expression levels of metabolic enzymes in normal skin versus precancerous lesions or skin cancer

    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.

    1 month

Study Arms (1)

skin specimen

skin specimen

Other: skin specimen

Interventions

skin specimen

skin specimen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Study population will be selected from University of California Irvine Medical Cencal

You may qualify if:

  • 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

You may not qualify if:

  • Male or Female are under 18 years of age
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beckman Laser Institute

Irvine, California, 92612, United States

Location

Gottschalk Medical Plaza, 1 Medical Plaza Drive

Irvine, California, 92697, United States

Location

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Kristen Kelly, MD

    Beckman Laser Institute, UCI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Kirsten Kelly, M.D., Professor of Dermatology and Surgery

Study Record Dates

First Submitted

September 10, 2014

First Posted

September 19, 2014

Study Start

March 1, 2011

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations