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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nevisense electrical impedance spectroscopy | Diagnostic Test | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Ashfaq Marghoob, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Consent only) | Basking Ridge | New Jersey | 07920 | United States | ||
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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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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| ID | Term |
|---|---|
| D009506 | Nevus |
| ID | Term |
|---|---|
| D018326 | Nevi and Melanomas |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| 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 |