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OpenTrials
Completed

NCT Number: NCT03080948

Risk Stratification Among Individuals Who Have Many Moles on Their Skin

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

survey

Behavioral

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

Saliva Samples

Other

Germline DNA analysis

Primary outcomes

  1. number of patients having specific dermoscopic patterns

    Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Princess Alexandra Hospital, Brisbane, Australia
  • Sheba Medical Center
  • Tel-Aviv Sourasky Medical Center

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Mar 15, 2017
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.