Clinical Trial: Prospective Study of 2 mm Margins for the Biopsy of Dysplastic Nevi

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Prospective Study of 2 mm Margins for the Biopsy of Dysplastic Nevi

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

Detailed Summary: 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.
Sponsor: New York University School of Medicine

Current Primary Outcome: Clear margins on the histopathological sections examined after a 2 mm saucerazation biopsy. [ Time Frame: Up to 1 year ]

Original Primary Outcome: Clear margins on the histopathological sections examined after a 2 mm saucerazation biopsy. [ Time Frame: Up to 1 year ]

Current Secondary Outcome: Nevus recurrence rate [ Time Frame: Up to 1 year ]

Original Secondary Outcome: Same as current

Information By: New York University School of Medicine

Dates:
Date Received: March 23, 2017
Date Started: February 25, 2013
Date Completion:
Last Updated: March 30, 2017
Last Verified: March 2017