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NCT03080948Completed

Risk Stratification Among Individuals Who Have Many Moles on Their Skin

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

Source: ClinicalTrials.gov · Last updated 2 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
73 (actual)
First submitted
10 Mar 2017
Start date
9 Mar 2017
Primary completion date
28 Nov 2025
Lead sponsor
Memorial Sloan Kettering Cancer Center
Diseases
Melanoma
NCT number
NCT03080948

What you commit to

  • Study type: Observational
  • Participants enrolled: 73
  • From 9 Mar 2017 to the primary completion date, 28 Nov 2025
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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.

Other illness

  • 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
  • History of limb amputation or other condition (e.g., tattoos, burns) per investigator discretion that would modify nevus phenotype
  • Known hypersensitivity to adhesive rings used for reflectance confocal microscopy
  • Have skin afflicted with anther skin condition (for example, psoriasis) that would affect ability to characterize nevus phenotype (per investigator discretion)

Age

  • Age 70 or above

Other

  • 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)
  • Physical inability to undergo total body photography or reflectance confocal microscopy imaging (that is, remain relatively still for durations of 3-5 minutes)
  • Inability to give informed consent

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Memorial Sloan Kettering Basking Ridge
Coordinator of this site? Confirm its status
Basking RidgeUnited StatesUnknown status
Memorial Sloan Kettering Westchester
Coordinator of this site? Confirm its status
HarrisonUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center Hauppauge
Coordinator of this site? Confirm its status
HauppaugeUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.