Using MC1R Genotype to Impact Melanoma Risk Behavior
Melanoma (Skin), Squamous Cell Carcinoma, Squamous Cell Cancer
About this trial
This is an interventional prevention trial for Melanoma (Skin) focused on measuring skin cancer prevention, educational materials, skin cancer risk, questionnaire, MC1R genotype
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)
Sites / Locations
- H. Lee Moffitt Cancer Center and Research Institute
- Ponce School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Intervention Group A
Intervention Group B
Control Group A
Control Group B
Intervention Group A: Non-Hispanic White Population Post determination of MC1R Genotypes, participants randomized to the intervention group, will receive personalized information about ways that they can protect themselves and their child from developing melanoma. By the end of the study, all participants will have had the opportunity to receive information about their inherited risk.
Intervention Group B: Hispanic Population Post determination of MC1R Genotypes, participants randomized to the intervention group, will receive personalized information about ways that they can protect themselves and their child from developing melanoma. By the end of the study, all participants will have had the opportunity to receive information about their inherited risk.
Control Group A: Non-Hispanic White Population Post determination of MC1R Genotypes, participants randomized to the control group, you will receive standard information about ways that they can protect themselves and their child from developing melanoma. By the end of the study, all participants will have had the opportunity to receive information about their inherited risk. Participants randomized into the control group, by the end of the study will also have had the opportunity to receive personalized information about ways they can protect themselves and their child from developing melanoma.
Control Group B: Hispanic Population Post determination of MC1R Genotypes, participants randomized to the control group, you will receive standard information about ways that they can protect themselves and their child from developing melanoma. By the end of the study, all participants will have had the opportunity to receive information about their inherited risk. Participants randomized into the control group, by the end of the study will also have had the opportunity to receive personalized information about ways they can protect themselves and their child from developing melanoma.