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CompletedNCT04705168Updated Nov 20, 2025

Study of the Nevisense Device to Assess Atypical Skin Lesions

An observational study in Nevus, Multiple Nevi and Large Acquired Nevi, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 3 sites in United States. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2025-11-20.

Sponsored by Memorial Sloan Kettering Cancer Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
30 Years and older
Sex
All
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Study summary

The purpose of this study is to find out whether the Nevisense device can provide useful information about atypical moles to complement the usual assessments done during routine screening for melanoma. Assessing particpants' moles with the Nevisense device may help improve screening methods for the early detection of melanoma in people with atypical mole syndrome.

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Conditions studied

  • Nevus
  • Multiple Nevi
  • Large Acquired Nevi
  • Skin Lesion

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Keywords

  • Atypical Skin Lesions
  • Skin Lesions
  • Multiple Nevi
  • Large Acquired Nevi
  • Memorial Sloan Kettering Cancer Center
  • 20-010
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Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan Kettering Cancer Center (MSKCC). If the investigator is a member of the treatment team, s/he will screen their patient's medical records for suitable research study participants and discuss the study and their potential for enrolling in the research study. Potential subjects contacted by their treating physician will be referred to the investigator/research staff of the study.

Inclusion criteria

  • Adult patients (> 30 years of age) at the time of the initial study visit.
  • Patients displaying a phenotype that consists of ≥ 100 nevi on the entire cutaneous surface and at least three large acquired nevi (LAN) > 5 mm in diameter. These patients have "atypical mole syndrome", which is a high-risk nevus phenotype and the target patient population in this study.
  • Patients with at least three clinically stable nevi between 5 and 20 mm in diameter.
  • Patients (or LAR) who are able to provide informed consent.
  • Patients with previous total body photography images taken at least 3 years prior

Exclusion criteria

Exclusion Criteria:

  • Patients without at least three clinically stable nevi between 5 and 20 mm in diameter.
  • Patients with any electronic implantable devices.
  • Patients who are pregnant (verbally confirmed with the participant).
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (actual)
Patient registry
No

Groups and cohorts

  • Participants displaying nevi

    Participants displaying a phenotype that consists of ≥ 100 nevi on the entire cutaneous surface and at least three large acquired nevi (LAN) \> 5 mm in diameter. These patients have "atypical mole syndrome", which is a high-risk nevus phenotype and the target patient population in this study.

    Diagnostic Test: Nevisense electrical impedance spectroscopy

Interventions

  • Diagnostic testNevisense electrical impedance spectroscopy

    Each participants will undergo Nevisense electrical impedance spectroscopy in order to characterize the electrical impedance spectroscopy scores of nevi in patients with ≥ 100 nevi on the entire cutaneous surface and at least three large acquired nevi (LAN) \> 5 mm in diameter

05

What researchers measure

Primary outcomes

  1. Electrical impedance spectroscopy scores of participants' nevi

    The primary objective is to characterize the electrical impedance spectroscopy scores of nevi in patients with ≥ 100 nevi on the entire cutaneous surface and at least three large acquired nevi (LAN) \> 5 mm in diameter.

    Time frame: 2 weeks

06

Study locations

3 sites
  • Memorial Sloan Kettering Basking Ridge (Consent only)
    Basking Ridge, New Jersey 07920, United States
  • Memorial Sloan Kettering Westchester (Consent only)
    Harrison, New York 10604, United States
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
    New York, New York 10065, United States
07

References and documents

Individual participant data

Plan to share: Yes — Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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Registry details

Key details

Study ID
NCT04705168
Lead sponsor
Memorial Sloan Kettering Cancer Center
Responsible party
Sponsor
First posted
Jan 12, 2021
Start date
Jan 8, 2021
Primary completion
Nov 18, 2025
Completion
Nov 18, 2025
Last update
Nov 20, 2025

Study contacts

Ashfaq Marghoob, MD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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