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
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge Coordinator of this site? Confirm its status | Basking Ridge | United States | Unknown status |
| Memorial Sloan Kettering Westchester Coordinator of this site? Confirm its status | Harrison | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center Hauppauge Coordinator of this site? Confirm its status | Hauppauge | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.