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Using MC1R Genotype to Impact Melanoma Risk Behavior

Primary Purpose

Melanoma (Skin), Squamous Cell Carcinoma, Squamous Cell Cancer

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Personalized Information
Standard Information
DNA Extraction Determination of MC1R Genotypes
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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)

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

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

Intervention Group A

Intervention Group B

Control Group A

Control Group B

Arm 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.

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.

Outcomes

Primary Outcome Measures

Sun and Protection Behaviors - Impact of Risk and Prevention Education - Non-Hispanic White Population
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
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
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
Rate of self-reported, post education changes per study arm: Increase in skin examinations.

Secondary Outcome Measures

Impact of Receipt of MC1R Genotype on Sun Protection Behaviors in Children - Non-Hispanic White Population
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
Impact of receipt of MC1R genotype on sun protection behaviors in children of study participants. Self-reported post education decreased number of sunburns.

Full Information

First Posted
April 17, 2018
Last Updated
November 15, 2021
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
The Ponce Health Sciences University, University of South Florida, American Cancer Society, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03509467
Brief Title
Using MC1R Genotype to Impact Melanoma Risk Behavior
Official Title
Using MC1R Genotype to Impact Melanoma Risk Behavior
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 3, 2015 (Actual)
Primary Completion Date
February 19, 2021 (Actual)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
The Ponce Health Sciences University, University of South Florida, American Cancer Society, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin), Squamous Cell Carcinoma, Squamous Cell Cancer, Skin Cancer, Basal Cell Carcinoma, Basal Cell Cancer
Keywords
skin cancer prevention, educational materials, skin cancer risk, questionnaire, MC1R genotype

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2293 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group A
Arm Type
Experimental
Arm 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.
Arm Title
Intervention Group B
Arm Type
Experimental
Arm 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.
Arm Title
Control Group A
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Control Group B
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Personalized Information
Other Intervention Name(s)
educational materials
Intervention Description
Personalized information about ways that participants can protect themselves and their child from developing melanoma.
Intervention Type
Behavioral
Intervention Name(s)
Standard Information
Other Intervention Name(s)
educational materials
Intervention Description
Standard information about ways that participants can protect themselves and their child from developing melanoma.
Intervention Type
Other
Intervention Name(s)
DNA Extraction Determination of MC1R Genotypes
Other Intervention Name(s)
risk factor
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sun and Protection Behaviors - Impact of Risk and Prevention Education - Non-Hispanic White Population
Description
Rate of self-reported, post education changes per study arm: 1.) decrease in sun exposure, 2.) increase in sun protection.
Time Frame
Up to 12 months
Title
Sun and Protection Behaviors - Impact of Risk and Prevention Education - Hispanic Population
Description
Rate of self-reported, post education changes per study arm: 1.) decrease in sun exposure, 2.) increase in sun protection
Time Frame
Up to 9 months
Title
Skin Awareness and Examination - Impact of Risk and Prevention Education - Hispanic Population
Description
Rate of self-reported, post education changes per study arm: Increase in skin examinations.
Time Frame
Up to 9 months
Title
Skin Awareness and Examination - Impact of Risk and Prevention Education - Non-Hispanic White Population
Description
Rate of self-reported, post education changes per study arm: Increase in skin examinations.
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Impact of Receipt of MC1R Genotype on Sun Protection Behaviors in Children - Non-Hispanic White Population
Description
Impact of receipt of MC1R genotype on sun protection behaviors in children of study participants. Self-reported post education decreased number of sunburns.
Time Frame
Up to 12 months
Title
Impact of Receipt of MC1R Genotype on Sun Protection Behaviors in Children - Hispanic Population
Description
Impact of receipt of MC1R genotype on sun protection behaviors in children of study participants. Self-reported post education decreased number of sunburns.
Time Frame
Up to 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Kanetsky, Ph.D
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Ponce School of Medicine
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
35552458
Citation
Lacson JCA, Forgas SM, Doyle SH, Qian L, Del Rio J, Valavanis S, Carvajal R, Gonzalez-Calderon G, Kim Y, Roetzheim RG, Vadaparampil ST, Kanetsky PA. Assessment of melanoma precision prevention materials incorporating MC1R genetic risk information. Transl Behav Med. 2022 May 26;12(5):683-687. doi: 10.1093/tbm/ibac034.
Results Reference
derived

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Using MC1R Genotype to Impact Melanoma Risk Behavior

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