Melanoma Clinical Trial

Risk Stratification Among Individuals Who Have Many Moles on Their Skin

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Melanoma

Estimated Enrollment:

73

Study ID:

NCT03080948

Recruitment Status:

Active, not recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

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There are 4 Locations for this study

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Memorial Sloan Kettering Basking Ridge
Basking Ridge New Jersey, 07920, United States
Memorial Sloan Kettering Westchester
Harrison New York, 10604, United States
Memorial Sloan Kettering Cancer Center Hauppauge
Hauppauge New York, 11788, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Estimated Enrollment:

73

Study ID:

NCT03080948

Recruitment Status:

Active, not recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

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