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Using MC1R Genotype to Impact Melanoma Risk Behavior

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Melanoma (Skin) Squamous Cell Carcinoma Squamous Cell Cancer Skin Cancer Basal Cell Carcinoma Basal Cell Cancer Behavioral: Personalized Information Behavioral: Standard Information Other: DNA Extraction Determination of MC1R Genotypes Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2293 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Using MC1R Genotype to Impact Melanoma Risk Behavior
Actual Study Start Date : August 3, 2015
Estimated Primary Completion Date : October 14, 2021
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
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.

Behavioral: Personalized Information
Personalized 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

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.

Behavioral: Personalized Information
Personalized 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

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.

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

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.

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




Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03509467


Locations
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United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Puerto Rico
Ponce School of Medicine
Ponce, Puerto Rico, 00716
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
The Ponce Health Sciences University
University of South Florida
American Cancer Society, Inc.
Investigators
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Principal Investigator: Peter Kanetsky, Ph.D H. Lee Moffitt Cancer Center and Research Institute
Additional Information:
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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT03509467    
Other Study ID Numbers: MCC-17984
MCC-19461 ( Other Identifier: H. Lee Moffitt Cancer and Research Center )
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: June 15, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
skin cancer prevention
educational materials
skin cancer risk
questionnaire
MC1R genotype
Additional relevant MeSH terms:
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Carcinoma
Melanoma
Carcinoma, Squamous Cell
Carcinoma, Basal Cell
Skin Neoplasms
Neoplasms, Squamous Cell
Neoplasms, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms by Site
Skin Diseases