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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

138 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-25

Study Completion Date

2016-03-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Dysplastic Nevi

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Saucerization biopsy

2 mm saucerization biopsy of dysplastic nevi

Intervention Type PROCEDURE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No