Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2026-01-02 @ 5:27 AM
Study NCT ID:
NCT04705168
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2021-01-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Nevisense Device to Assess Atypical Skin Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009506', 'term': 'Nevus'}], 'ancestors': [{'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-11-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2021-01-08', 'studyFirstSubmitQcDate': '2021-01-08', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Electrical impedance spectroscopy scores of participants' nevi", 'timeFrame': '2 weeks', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atypical Skin Lesions', 'Skin Lesions', 'Multiple Nevi', 'Large Acquired Nevi', 'Memorial Sloan Kettering Cancer Center', '20-010'], 'conditions': ['Nevus', 'Multiple Nevi', 'Large Acquired Nevi', 'Skin Lesion']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "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.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (\\> 30 years of age) at the time of the initial study visit.\n* 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.\n* Patients with at least three clinically stable nevi between 5 and 20 mm in diameter.\n* Patients (or LAR) who are able to provide informed consent.\n* Patients with previous total body photography images taken at least 3 years prior\n\nExclusion Criteria:\n\n* Patients without at least three clinically stable nevi between 5 and 20 mm in diameter.\n* Patients with any electronic implantable devices.\n* Patients who are pregnant (verbally confirmed with the participant).'}, 'identificationModule': {'nctId': 'NCT04705168', 'briefTitle': 'Study of the Nevisense Device to Assess Atypical Skin Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Performance of Nevisense Electrical Impedance Spectroscopy in Patients With Multiple Nevi and Large Acquired Nevi (LAN)', 'orgStudyIdInfo': {'id': '21-010'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants displaying nevi', 'description': '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.', 'interventionNames': ['Diagnostic Test: Nevisense electrical impedance spectroscopy']}], 'interventions': [{'name': 'Nevisense electrical impedance spectroscopy', 'type': 'DIAGNOSTIC_TEST', 'description': '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', 'armGroupLabels': ['Participants displaying nevi']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Basking Ridge (Consent only)', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}, {'zip': '10604', 'city': 'Harrison', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Westchester (Consent only)', 'geoPoint': {'lat': 40.96899, 'lon': -73.71263}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center (All Protocol Activities)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Ashfaq Marghoob, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}