Prospective Study of 2 mm Margins for the Biopsy of Dysplastic Nevi
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03094273|
Recruitment Status : Completed
First Posted : March 29, 2017
Last Update Posted : May 8, 2019
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|Condition or disease||Intervention/treatment|
|Dysplastic Nevi||Procedure: Saucerization biopsy|
|Study Type :||Observational|
|Actual Enrollment :||138 participants|
|Official Title:||Prospective Study of 2 mm Margins for the Biopsy of Dysplastic Nevi|
|Actual Study Start Date :||February 25, 2013|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||March 2016|
- Procedure: Saucerization biopsy
2 mm saucerization biopsy of dysplastic nevi
- Clear margins on the histopathological sections examined after a 2 mm saucerazation biopsy. [ Time Frame: Up to 1 year ]2 mm saucerization biopsy
- Nevus recurrence rate [ Time Frame: Up to 1 year ]To determine the rate of nevus recurrence within 1 year of follow-up
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- All patents seen in the practices of the study physicians are eligible to participate in the study.
- Patients must be over 18 years of age.
- Patients who are able to provide informed consent.
- Patient must have a lesion in which the differential diagnosis includes a DN and for which the study dermatologist deems it is appropriate to perform a saucerization biopsy.
- Patients who are less than 18 years of age.
- Patients who are unable to provide informed consent.
- Lesions for which a saucerization biopsy is impractical in the judgment of the study dermatologist based on certain clinical factors (e.g. patient on anticoagulation therapy, lesion size and/or anatomic location).
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): NCT03094273
|United States, New York|
|Laura & Isaac Perlmutter Cancer Center & NYU Langone Medical Center|
|New York, New York, United States, 10016|
|Principal Investigator:||David Polsky, MD, PhD||NYU Langone Health|
|Responsible Party:||NYU Langone Health|
|Other Study ID Numbers:||
|First Posted:||March 29, 2017 Key Record Dates|
|Last Update Posted:||May 8, 2019|
|Last Verified:||May 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Dysplastic Nevus Syndrome
Nevi and Melanomas
Neoplasms by Histologic Type
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn