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

Dysplastic Nevi Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03094273
• Other study ID #: 12-03921
• Status: Completed
• Start date: February 25, 2013
• Est. completion date: March 2016

Study information

• Verified date: May 2019
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: March 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Dysplastic Nevi
• Dysplastic Nevus Syndrome
• Hyperplasia
• Nevus

Intervention

Procedure:
• Saucerization biopsy
2 mm saucerization biopsy of dysplastic nevi

Locations

Country	Name	City	State
United States	Laura & Isaac Perlmutter Cancer Center & NYU Langone Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (1)

Terushkin V, Ng E, Stein JA, Katz S, Cohen DE, Meehan S, Polsky D. A prospective study evaluating the utility of a 2-mm biopsy margin for complete removal of histologically atypical (dysplastic) nevi. J Am Acad Dermatol. 2017 Dec;77(6):1096-1099. doi: 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clear margins on the histopathological sections examined after a 2 mm saucerazation biopsy.	2 mm saucerization biopsy	Up to 1 year
Secondary	Nevus recurrence rate	To determine the rate of nevus recurrence within 1 year of follow-up	Up to 1 year