Prospective Study of 2 mm Margins for the Biopsy of Dysplastic Nevi

Completed

• Conditions: Dysplastic Nevi

• Registration Number: NCT03094273
• Lead Sponsor: NYU Langone Health

Brief Summary

Non-interventional study to evaluate the utility of removing Dysplastic Nevi with a defined 2 mm margin.

Detailed Description

This is a prospective, observational study to evaluate the utility of removing Dysplastic Nevi (DN) with a defined 2 mm margin. This is a non-interventional study that will observe the pathology results following a standard of care biopsy. Principal Investigator (PI) hypothesize that the majority of lesions removed with this technique will have margins free of nevus cells on examination of histopathological sections. Hence, pathologists will not suggest that an additional excision be performed to remove any residual nevus. PI also hypothesize that if biopsy sites are followed over time, the rate of nevus recurrence will be low, because investigators would have removed the majority, if not all of the lesion at the time of initial biopsy.

Study Timeline

• Study Start: 2013-02-25
• Primary Completion: 2016-01
• Study Completion: 2016-03
• Study First Submitted: 2017-03-23
• Study First Submitted QC: 2017-03-23
• Study First Posted: 2017-03-29
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-06
• Last Update Posted: 2019-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clear margins on the histopathological sections examined after a 2 mm saucerazation biopsy.	Up to 1 year	2 mm saucerization biopsy

Secondary Outcome Measures

Name	Time	Method
Nevus recurrence rate	Up to 1 year	To determine the rate of nevus recurrence within 1 year of follow-up

Trial Locations

Locations (1)

Laura & Isaac Perlmutter Cancer Center & NYU Langone Medical Center; 🇺🇸 New York, New York, United States