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Using MC1R Genotype to Impact Melanoma Risk Behavior

NCT ID: NCT03509467

Last Updated: 2025-12-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2054 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-03

Study Completion Date

2021-02-19

Brief Summary

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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

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Conditions

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

Keywords

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skin cancer prevention educational materials skin cancer risk questionnaire MC1R genotype

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Personalized Information

Intervention Type BEHAVIORAL

Personalized information about ways that participants can protect themselves and their child from developing melanoma.

DNA Extraction Determination of MC1R Genotypes

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

Personalized Information

Intervention Type BEHAVIORAL

Personalized information about ways that participants can protect themselves and their child from developing melanoma.

DNA Extraction Determination of MC1R Genotypes

Intervention Type OTHER

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.

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.

Group Type PLACEBO_COMPARATOR

Standard Information

Intervention Type BEHAVIORAL

Standard information about ways that participants can protect themselves and their child from developing melanoma.

DNA Extraction Determination of MC1R Genotypes

Intervention Type OTHER

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.

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.

Group Type PLACEBO_COMPARATOR

Standard Information

Intervention Type BEHAVIORAL

Standard information about ways that participants can protect themselves and their child from developing melanoma.

DNA Extraction Determination of MC1R Genotypes

Intervention Type OTHER

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.

Interventions

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Personalized Information

Personalized information about ways that participants can protect themselves and their child from developing melanoma.

Intervention Type BEHAVIORAL

Standard Information

Standard information about ways that participants can protect themselves and their child from developing melanoma.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Other Intervention Names

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educational materials educational materials risk factor

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ponce Health Sciences University

OTHER

Sponsor Role collaborator

University of South Florida

OTHER

Sponsor Role collaborator

American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Kanetsky, Ph.D

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Locations

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H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Site Status

Ponce School of Medicine

Ponce, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

References

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Rivera Rivera JN, Lacson JCA, Kim Y, Roetzheim RG, Sutton SK, Soto-Torres B, Vadaparampil ST, Kanetsky PA. Sharing and seeking information about skin cancer risk and prevention among Hispanic people from Florida and Puerto Rico. PEC Innov. 2023 Nov 14;3:100232. doi: 10.1016/j.pecinn.2023.100232. eCollection 2023 Dec 15.

Reference Type DERIVED
PMID: 38028436 (View on PubMed)

Lacson JCA, Sutton SK, Kim Y, Roetzheim RG, Vadaparampil ST, Soto-Torres B, Kanetsky PA. Predictors of correct recall of genetic risk information among Hispanic individuals in Florida and Puerto Rico. Patient Educ Couns. 2023 Dec;117:107978. doi: 10.1016/j.pec.2023.107978. Epub 2023 Sep 11.

Reference Type DERIVED
PMID: 37708699 (View on PubMed)

Lacson JCA, Kim Y, Roetzheim RG, Sutton SK, Vadaparampil ST, Kanetsky PA. Predictors of genetic risk recall among the participants of a randomized controlled precision prevention trial against melanoma. Genet Med. 2023 Apr;25(4):100005. doi: 10.1016/j.gim.2023.100005. Epub 2023 Jan 7.

Reference Type DERIVED
PMID: 36629029 (View on PubMed)

Lacson JCA, Doyle SH, Del Rio J, Forgas SM, Carvajal R, Gonzalez-Calderon G, Feliciano AR, Kim Y, Roetzheim RG, Sutton SK, Vadaparampil ST, Soto-Torres B, Kanetsky PA. A randomized clinical trial of precision prevention materials incorporating MC1R genetic risk to improve skin cancer prevention activities among Hispanics. Cancer Res Commun. 2022 Jan;2(1):28-38. doi: 10.1158/2767-9764.crc-21-0114. Epub 2022 Jan 11.

Reference Type DERIVED
PMID: 35845857 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35552458 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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MCC-19461

Identifier Type: OTHER

Identifier Source: secondary_id

MCC-17984

Identifier Type: -

Identifier Source: org_study_id