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

NYU Langone Health

Status: Completed

Conditions: Dysplastic Nevi

Treatments: Procedure: Saucerization biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT03094273

12-03921

Details and patient eligibility

About

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

Full 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.

Enrollment: 138 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

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).