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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03094273

Enrollment

138

Registered

2017-03-29

Start date

2013-02-25

Completion date

2016-03-31

Last updated

2019-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysplastic Nevi

Keywords

Melanocytic neoplasm, Biopsy, Saucerization biopsy, Skin lesion

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.

Interventions

PROCEDURESaucerization biopsy

2 mm saucerization biopsy of dysplastic nevi

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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).

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Nevus recurrence rate	Up to 1 year	To determine the rate of nevus recurrence within 1 year of follow-up

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026