Risk Stratification Among Individuals Who Have Many Moles on Their Skin

Cutaneous Melanoma Risk Stratification of Individuals With a High-Risk Nevus Phenotype

The investigators are doing this study to improve our ability to identify which people with many moles on their skin are most likely to develop skin melanoma. The investigators hope to identify features of moles that are associated with melanoma risk. The investigators hope to use this information to customize and tailor melanoma screening to the individual patient based on a better estimate of their individual risk.

Study Overview

• Status: Active, not recruiting
• Conditions: High-Risk Nevus Phenotype
• Intervention / Treatment: Behavioral: survey; Other: Saliva samples

• Study Type: Observational
• Enrollment (Actual): 73

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Memorial Sloan Kettering Basking Ridge
  • New York
    • Harrison, New York, United States, 10604
      • Memorial Sloan Kettering Westchester
    • Hauppauge, New York, United States, 11788
      • Memorial Sloan Kettering Cancer Center Hauppauge
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients in the Melanoma Screening and Surveillance Program (MSSP).

Description

Inclusion Criteria:

• Patients ≥ 18 years of age
• High-risk nevus phenotype (≥ 50 nevi (≥ 2mm in size) and ≥ 1 atypical nevus)
• First presented to MSKCC for cutaneous melanoma-related care on or after April 2016
• Cases: diagnoses of unequivocal invasive cutaneous melanomas (AJCC Stages I-IV) confirmed by MSKCC pathology on or after April 2016
• Cases: completion of surgical treatment of primary melanoma
• Ability to sign or verbally consent to the informed consent

Exclusion Criteria:

• Controls: Histopathologically borderline melanocytic tumors for which melanoma could not be excluded or that were treated as possible melanomas.
• Known germline high-penetrance melanoma predisposition mutation (that is, CDKN2A, CDK4, and BAP1)
• Cases: history of invasive cutaneous melanoma (AJCC Stages I-IV) not confirmed by MSKCC pathology
• History of acrolentiginous type of cutaneous melanoma or history of mucosal melanoma
• Cases and controls: prior administration of systemic medications known to modify nevus phenotype, including but not limited to: MEK inhibitors (trametinib, cobimetinib, etc.), BRAF inhibitors (vemurafenib, dabrafenib, etc.), and immunotherapy (pembrolizumab, nivolumab, atezolizumab, ipilimumab, etc.). Controls: history of Stage 0-IV melanoma confirmed by MSKCC pathology
• History of limb amputation or other condition (e.g., tattoos, burns) per investigator discretion that would modify nevus phenotype
• Physical inability to undergo total body photography or reflectance confocal microscopy imaging (that is, remain relatively still for durations of 3-5 minutes)
• Known hypersensitivity to adhesive rings used for reflectance confocal microscopy
• Inability to give informed consent
• Have skin afflicted with anther skin condition (for example, psoriasis) that would affect ability to characterize nevus phenotype (per investigator discretion)
• Familial cutaneous melanoma history (families with at least one invasive melanoma and two or more other diagnoses of invasive melanoma or pancreatic cancer among first- or second-degree relatives on the same side of the family). We will confirm melanoma family history via medical record documentation, whenever possible, as recommended by previous studies that disproved about half of the reported family histories of melanoma among first-degree relatives in case-control studies.
• Age 70 or above

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
History of Melanoma (cases); Participants at high-risk for melanoma (that is, those having many nevi and morphologically atypical nevi) who either have a history of invasive melanoma (cases) or do not have a history of melanoma (controls) and will perform comprehensive total body imaging of their moles in order to identify phenotypic markers of melanoma risk that aid in melanoma risk stratification. In addition, we will investigate histopathologic and molecular features of moles that are associated with melanoma risk and with melanoma subtypes. The evaluations needed for this study protocol will be primarily performed during routine clinical care.	Behavioral: survey; Research assessments as part of this protocol will be scheduled during routine clinic visits; Other: Saliva samples; Germline DNA analysis
No Melanoma History (controls); Participants at high-risk for melanoma (that is, those having many nevi and morphologically atypical nevi) who either have a history of invasive melanoma (cases) or do not have a history of melanoma (controls) and will perform comprehensive total body imaging of their moles in order to identify phenotypic markers of melanoma risk that aid in melanoma risk stratification. In addition, we will investigate histopathologic and molecular features of moles that are associated with melanoma risk and with melanoma subtypes. The evaluations needed for this study protocol will be primarily performed during routine clinical care.	Behavioral: survey; Research assessments as part of this protocol will be scheduled during routine clinic visits; Other: Saliva samples; Germline DNA analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of patients having specific dermoscopic patterns	For each person, the proportions of their nevi having specific dermoscopic patterns will be calculated.	2 years

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Tel-Aviv Sourasky Medical Center; Sheba Medical Center; Princess Alexandra Hospital, Brisbane, Australia
• Investigators: Principal Investigator: Allan Halpern, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2017
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: March 10, 2017
• First Submitted That Met QC Criteria: March 10, 2017
• First Posted (Actual): March 15, 2017

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Nevi and Melanomas; Nevus
• Other Study ID Numbers: 17-083

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No