Clinical trial · Interventional
Using MC1R Genotype to Impact Melanoma Risk Behavior
NCT03509467CI-TRIAL-00099378completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Cell Cancer | Skin Basal Cell Carcinoma | ALIAS | 0.90 |
| Basal Cell Carcinoma | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
| Squamous Cell Cancer | Squamous Cell Carcinoma | ALIAS | 0.90 |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DNA Extraction Determination of MC1R Genotypes | Other | — | UNRESOLVED |
| Personalized Information | Behavioral | — | UNRESOLVED |
| Standard Information | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Intervention Group A
- 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.
- interventionNames
- Behavioral: Personalized Information
- Other: DNA Extraction Determination of MC1R Genotypes
- type
- EXPERIMENTAL
- label
- Intervention Group B
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (5)
- DERIVEDRivera 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. PMID 38028436
- DERIVEDLacson 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. PMID 37708699
- DERIVEDLacson 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. PMID 36629029
- DERIVEDLacson 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. PMID 35845857
- DERIVEDLacson 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. PMID 35552458