Risk Stratification Among Individuals Who Have Many Moles on Their Skin

NCT03080948 | Completed

• 1 other identifier: 17-083
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

High-Risk Nevus Phenotype

Outcome Measures

Primary Outcomes (1)

• number of patients having specific dermoscopic patterns

  For each person, the proportions of their nevi having specific dermoscopic patterns will be calculated.

  2 years

Study Arms (2)

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; Other: Saliva samples

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; Other: Saliva samples

Interventions

survey BEHAVIORAL

Research assessments as part of this protocol will be scheduled during routine clinic visits

History of Melanoma (cases); No Melanoma History (controls)

Saliva samples OTHER

Germline DNA analysis

History of Melanoma (cases); No Melanoma History (controls)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Princess Alexandra Hospital, Brisbane, Australia: collaborator
• Sheba Medical Center: collaborator
• Tel-Aviv Sourasky Medical Center: collaborator

Study Sites (4)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center Hauppauge

Hauppauge, New York, 11788, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

saliva

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Allan Halpern, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: March 15, 2017
• Study Start: March 9, 2017
• Primary Completion: November 28, 2025
• Study Completion: November 28, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-12

Locations

US (4)