Risk Stratification Among Individuals Who Have Many Moles on Their Skin



Status:Enrolling by invitation
Healthy:No
Age Range:18 - Any
Updated:2/17/2019
Start Date:March 9, 2017
End Date:March 2019

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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.


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 within the past 12 months

- Cases: recent diagnosis (≤ 12 months) of unequivocal invasive cutaneous melanomas
(AJCC Stages I-IV) confirmed by MSKCC pathology

- Cases: completion of surgical treatment of primary melanoma

- Ability to sign 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
We found this trial at
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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