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Using MC1R Genotype to Impact Melanoma Risk Behavior

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ClinicalTrials.gov Identifier: NCT03509467
Recruitment Status : Active, not recruiting
First Posted : April 26, 2018
Last Update Posted : June 15, 2021
Sponsor:
Collaborators:
The Ponce Health Sciences University
University of South Florida
American Cancer Society, Inc.
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Tracking Information
First Submitted Date  ICMJE April 17, 2018
First Posted Date  ICMJE April 26, 2018
Last Update Posted Date June 15, 2021
Actual Study Start Date  ICMJE August 3, 2015
Estimated Primary Completion Date October 14, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2020)
  • Sun and Protection Behaviors - Impact of Risk and Prevention Education - Non-Hispanic White Population [ Time Frame: Up to 12 months ]
    Rate of self-reported, post education changes per study arm: 1.) decrease in sun exposure, 2.) increase in sun protection.
  • Sun and Protection Behaviors - Impact of Risk and Prevention Education - Hispanic Population [ Time Frame: Up to 9 months ]
    Rate of self-reported, post education changes per study arm: 1.) decrease in sun exposure, 2.) increase in sun protection
  • Skin Awareness and Examination - Impact of Risk and Prevention Education - Hispanic Population [ Time Frame: Up to 9 months ]
    Rate of self-reported, post education changes per study arm: Increase in skin examinations.
  • Skin Awareness and Examination - Impact of Risk and Prevention Education - Non-Hispanic White Population [ Time Frame: Up to 12 months ]
    Rate of self-reported, post education changes per study arm: Increase in skin examinations.
Original Primary Outcome Measures  ICMJE
 (submitted: April 17, 2018)
  • Sun and Protection Behaviors - Impact of Risk and Prevention Education [ Time Frame: Up to 12 months ]
    Rate of self-reported, post education changes per ethnic group: 1.) decrease in sun exposure, 2.) increase in sun protection.
  • Skin Awareness and Examination - Impact of Risk and Prevention Education [ Time Frame: Up to 12 months ]
    Rate of self-reported, post education changes per ethnic group: Increase in skin examinations.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2018)
  • Impact of Receipt of MC1R Genotype on Sun Protection Behaviors in Children - Non-Hispanic White Population [ Time Frame: Up to 12 months ]
    Impact of receipt of MC1R genotype on sun protection behaviors in children of study participants. Self-reported post education decreased number of sunburns.
  • Impact of Receipt of MC1R Genotype on Sun Protection Behaviors in Children - Hispanic Population [ Time Frame: Up to 9 months ]
    Impact of receipt of MC1R genotype on sun protection behaviors in children of study participants. Self-reported post education decreased number of sunburns.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2018)
Impact of Receipt of MC1R Genotype on Sun Protection Behaviors in Children [ Time Frame: Up to 12 months ]
Impact of receipt of MC1R genotype on sun protection behaviors in children of study participants. Self-reported post education decreased number of sunburns.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Using MC1R Genotype to Impact Melanoma Risk Behavior
Official Title  ICMJE Using MC1R Genotype to Impact Melanoma Risk Behavior
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Melanoma (Skin)
  • Squamous Cell Carcinoma
  • Squamous Cell Cancer
  • Skin Cancer
  • Basal Cell Carcinoma
  • Basal Cell Cancer
Intervention  ICMJE
  • Behavioral: Personalized Information
    Personalized information about ways that participants can protect themselves and their child from developing melanoma.
    Other Name: educational materials
  • Behavioral: Standard Information
    Standard information about ways that participants can protect themselves and their child from developing melanoma.
    Other Name: educational materials
  • Other: DNA Extraction Determination of MC1R Genotypes
    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.
    Other Name: risk factor
Study Arms  ICMJE
  • Experimental: Intervention Group A

    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.

    Interventions:
    • Behavioral: Personalized Information
    • Other: DNA Extraction Determination of MC1R Genotypes
  • Experimental: Intervention Group B

    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.

    Interventions:
    • Behavioral: Personalized Information
    • Other: DNA Extraction Determination of MC1R Genotypes
  • Placebo Comparator: Control Group A

    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.

    Interventions:
    • Behavioral: Standard Information
    • Other: DNA Extraction Determination of MC1R Genotypes
  • Placebo Comparator: Control Group B

    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.

    Interventions:
    • Behavioral: Standard Information
    • Other: DNA Extraction Determination of MC1R Genotypes
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 31, 2020)
2293
Original Estimated Enrollment  ICMJE
 (submitted: April 17, 2018)
1312
Estimated Study Completion Date  ICMJE October 2022
Estimated Primary Completion Date October 14, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03509467
Other Study ID Numbers  ICMJE MCC-17984
MCC-19461 ( Other Identifier: H. Lee Moffitt Cancer and Research Center )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party H. Lee Moffitt Cancer Center and Research Institute
Study Sponsor  ICMJE H. Lee Moffitt Cancer Center and Research Institute
Collaborators  ICMJE
  • The Ponce Health Sciences University
  • University of South Florida
  • American Cancer Society, Inc.
Investigators  ICMJE
Principal Investigator: Peter Kanetsky, Ph.D H. Lee Moffitt Cancer Center and Research Institute
PRS Account H. Lee Moffitt Cancer Center and Research Institute
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP