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Physical Examination for Melanoma

N/A
Waitlist Available
Led By Pamela Cassidy
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 18-100 years. The investigators anticipate recruiting few if any patients over age 80 as nevi tend to disappear as people age. Both men and women of all races and ethnic groups will be included
Participants must have 2 clinically benign melanocytic nevi 3-5 mm in diameter confirmed by clinical dermatoscopic examination by a medically-qualified study team member and suitable for biopsy (i.e. not at a site that would be functionally or cosmetically damaged by the biopsy). The minimum size restriction arises from the need for collection of tissue sufficient for single nucleus ribonucleic acid sequencing (RNAseq) analysis. The maximum size is dictated by the requirement that the entire nevus be removed with a 6 mm punch biopsy, thereby eliminating any concerns that might arise from regrowth of the nevus that can happen after incomplete removal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study Summary

This trial is testing whether a new drug can help prevent skin cancer by looking at how it affects biomarkers in the skin after exposure to simulated solar radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of pixels positive for p53 by immunohistochemical analysis
Secondary outcome measures
Deoxyribonucleic acid (DNA) damage
Difference in the number of sunburn cells per high power field in irradiated and unirradiated control nevi
Percent of the area of the epidermis that is positive for Langerhans cells

Trial Design

3Treatment groups
Experimental Treatment
Group I: Group III (high dose simulated sunlight)Experimental Treatment2 Interventions
Patients undergo total body exam. The minimum dose of simulated sunlight required to cause mild sunburn is determined. One of the patient's moles is exposed to 6 times that minimum dose of simulated sunlight. One day later, that mole, and an untreated mole, are removed by punch biopsy.
Group II: Group II (middle dose simulated sunlight)Experimental Treatment2 Interventions
Patients undergo total body exam. The minimum dose of simulated sunlight required to cause mild sunburn is determined. One of the patient's moles is exposed to 4 times that minimum dose of simulated sunlight. One day later, that mole, and an untreated mole, are removed by punch biopsy.
Group III: Group I (low dose simulated sunlight)Experimental Treatment2 Interventions
Patients undergo total body exam. The minimum dose of simulated sunlight required to cause mild sunburn is determined. One of the patient's moles is exposed to 3 times that minimum dose of simulated sunlight. One day later, that mole, and an untreated mole, are removed by punch biopsy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Physical Examination
2019
N/A
~1140

Find a Location

Who is running the clinical trial?

OHSU Knight Cancer InstituteLead Sponsor
225 Previous Clinical Trials
2,090,465 Total Patients Enrolled
5 Trials studying Melanoma
75,323 Patients Enrolled for Melanoma
Oregon Health and Science UniversityOTHER
966 Previous Clinical Trials
6,845,745 Total Patients Enrolled
4 Trials studying Melanoma
75,393 Patients Enrolled for Melanoma
Pamela CassidyPrincipal InvestigatorOHSU Knight Cancer Institute
1 Previous Clinical Trials
100 Total Patients Enrolled
1 Trials studying Melanoma
100 Patients Enrolled for Melanoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~2 spots leftby Mar 2025