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Study of the Nevisense Device to Assess Atypical Skin Lesions

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ClinicalTrials.gov Identifier: NCT04705168
Recruitment Status : Recruiting
First Posted : January 12, 2021
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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
Nevus Multiple Nevi Large Acquired Nevi Skin Lesion Diagnostic Test: Nevisense electrical impedance spectroscopy

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Study Type : Observational
Estimated 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 : January 8, 2021
Estimated Primary Completion Date : January 8, 2022
Estimated Study Completion Date : January 8, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Birthmarks Moles

Group/Cohort 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




Primary Outcome Measures :
  1. Electrical impedance spectroscopy scores of participants' nevi [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04705168


Contacts
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Contact: Ashfaq Marghoob, MD 631-863-5116 marghooa@MSKCC.ORG
Contact: Michael Marchetti, MD 646-608-2357 marchetm@mskcc.org

Locations
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United States, New Jersey
Memoral Sloan Kettering Basking Ridge (Consent only) Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Ashfaq Marghoob, MD    631-863-5116      
United States, New York
Memoral Sloan Kettering Westchester (Consent only) Recruiting
Harrison, New York, United States, 10604
Contact: Ashfaq Marghoob, MD    631-863-5116      
Memorial Sloan Kettering Cancer Center (All Protocol Activities) Recruiting
New York, New York, United States, 10065
Contact: Ashfaq Marghoob, MD    631-863-5116      
Contact: E.         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Ashfaq Marghoob, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04705168    
Other Study ID Numbers: 21-010
First Posted: January 12, 2021    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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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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:
Atypical Skin Lesions
Skin Lesions
Multiple Nevi
Large Acquired Nevi
Memorial Sloan Kettering Cancer Center
20-010
Additional relevant MeSH terms:
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Nevus
Nevi and Melanomas
Neoplasms by Histologic Type
Neoplasms