Study of the Nevisense Device to Assess Atypical Skin Lesions

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04705168
Collaborator
(none)
50
3
24
16.7
0.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Nevisense electrical impedance spectroscopy

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Performance of Nevisense Electrical Impedance Spectroscopy in Patients With Multiple Nevi and Large Acquired Nevi (LAN)
Actual Study Start Date :
Jan 8, 2021
Anticipated Primary Completion Date :
Jan 8, 2023
Anticipated Study Completion Date :
Jan 8, 2023

Arms and Interventions

Arm Intervention/Treatment
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
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

Outcome Measures

Primary Outcome Measures

  1. Electrical impedance spectroscopy scores of participants' nevi [2 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Memoral Sloan Kettering Basking Ridge (Consent only) Basking Ridge New Jersey United States 07920
2 Memoral Sloan Kettering Westchester (Consent only) Harrison New York United States 10604
3 Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York New York United States 10065

Sponsors and Collaborators

  • Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Ashfaq Marghoob, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT04705168
Other Study ID Numbers:
  • 21-010
First Posted:
Jan 12, 2021
Last Update Posted:
Jan 11, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2022