Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT03509467
Eligibility Criteria:
Inclusion Criteria:
CRITERIA FOR: NON-HISPANIC WHITE POPULATION
* Investigators will recruit participants from the Family Medicine and General Internal Medicine clinics of the Morsani Center at the University of South Florida.
* White, non-Hispanic patients who self-report a low phenotypic risk profile for development of melanoma and are able to read and speak English fluently.
* 18 years of age or older
* Capable of giving informed consent
* Potential participants will be screened for eligibility based on responses to questions about skin phenotypes, early detection behaviors and past history of melanoma.
* After signing informed consent, a biologic sample (saliva) will be collected for the purpose of DNA extraction determination of MC1R genotypes. All participants who carry high risk MC1R genotypes and a proportion of those who carry low risk or no MC1R variants will be randomized to the control or intervention arm.
CRITERIA FOR: HISPANIC POPULATION
* Investigators will recruit participants living in Tampa Bay and Puerto Rico as part of the U54 Ponce Health Sciences University-Moffitt Cancer Center (PHSU-MCC) Partnership. In Tampa Bay, participants will be recruited from the Family Medicine and General Internal Medicine clinics of the Morsani Center at the University of South Florida, and from the Suncoast Community Health Centers.
* Patients who self-report as Hispanics and are able to read and speak either Spanish or English fluently.
* 18 years of age or older
* Capable of giving informed consent
* Potential participants will be screened for eligibility based on responses to early detection behaviors and past history of melanoma.
* After signing informed consent, a biologic sample (saliva) will be collected for the purpose of DNA extraction determination of MC1R genotypes. All participants who carry high risk MC1R genotypes and a proportion of those who carry low risk or no MC1R variants will be randomized to the control or intervention arm.
Exclusion Criteria:
CRITERIA FOR: NON-HISPANIC WHITE POPULATION
* Have had a skin examination within the past year.
* Do not meet race/ethnicity criteria for their group
* White, non-Hispanic group - participants reporting sun-sensitive phenotypes
* A personal history of melanoma
CRITERIA FOR: HISPANIC POPULATION
* Have had a skin examination within the past year.
* Do not meet ethnicity criteria for their group
* White, non-Hispanic group - participants reporting sun-sensitive phenotypes
* Participants with a personal history of melanoma and/or more personal history of more than on squamous cell cancer (SCC) and/or Basal Cell Cancer (BCC)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03509467
Study Brief:
Protocol Section:
NCT03509467