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Completed

NCT Number: NCT03094273

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Saucerization biopsy

Procedure

2 mm saucerization biopsy of dysplastic nevi

Primary outcomes

  1. Clear margins on the histopathological sections examined after a 2 mm saucerazation biopsy.

    Time frame: Up to 1 year

    2 mm saucerization biopsy

Secondary outcomes

  1. Nevus recurrence rate

    Time frame: Up to 1 year

    To determine the rate of nevus recurrence within 1 year of follow-up

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Mar 29, 2017
Registry last updated
May 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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