Using MC1R Genotype to Impact Melanoma Risk Behavior
Status
Completed
Conditions
Squamous Cell Carcinoma
Squamous Cell Cancer
Basal Cell Cancer
Melanoma (Skin)
Skin Cancer
Basal Cell Carcinoma
Treatments
Other: DNA Extraction Determination of MC1R Genotypes
Behavioral: Personalized Information
Behavioral: Standard Information
Study type
Interventional
Funder types
Other
Identifiers
Details and patient eligibility
About
The purpose of this study is to examine how different messages about risk of melanoma can impact the way people protect themselves against developing these diseases.
Enrollment
2,054 patients
Sex
All
Ages
18+ years old
Volunteers
Accepts Healthy Volunteers
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)
Trial design
Primary purpose
Prevention
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
2,054 participants in 4 patient groups, including a placebo group
Intervention Group A
Experimental group
Description:
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.
Treatment:
Other: DNA Extraction Determination of MC1R Genotypes
Behavioral: Personalized Information
Intervention Group B
Experimental group
Description:
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.
Treatment:
Other: DNA Extraction Determination of MC1R Genotypes
Behavioral: Personalized Information
Control Group A
Placebo Comparator group
Description:
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.
Treatment:
Other: DNA Extraction Determination of MC1R Genotypes
Behavioral: Standard Information
Control Group B
Placebo Comparator group
Description:
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.
Treatment:
Other: DNA Extraction Determination of MC1R Genotypes
Behavioral: Standard Information
Trial contacts and locations
2
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Data sourced from clinicaltrials.gov
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