Clinical trial NCT04705168: Study of the Nevisense Device to Assess Atypical Skin Lesions
Official title: Performance of Nevisense Electrical Impedance Spectroscopy in Patients With Multiple Nevi and Large Acquired Nevi (LAN)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Nevus
Multiple Nevi
Large Acquired Nevi
Skin Lesion
Keywords: Atypical Skin Lesions
Skin Lesions
Multiple Nevi
Large Acquired Nevi
Memorial Sloan Kettering Cancer Center
20-010
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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:

* 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).

Primary outcomes:
measure: Electrical impedance spectroscopy scores of participants' nevi
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Consent only)
state: New Jersey
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Consent only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Ashfaq Marghoob, MD
role: PRINCIPAL_INVESTIGATOR
References: