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

NCT03094273 | Completed

• 1 other identifier: 12-03921
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dysplastic Nevi

Keywords

Melanocytic neoplasm; Biopsy; Saucerization biopsy; Skin lesion

Outcome Measures

Primary Outcomes (1)

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

  2 mm saucerization biopsy

  Up to 1 year

Secondary Outcomes (1)

• Nevus recurrence rate

  Up to 1 year

Interventions

Saucerization biopsy PROCEDURE

2 mm saucerization biopsy of dysplastic nevi

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

NYU Dermatology Faculty Practice

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

Laura & Isaac Perlmutter Cancer Center & NYU Langone Medical Center

New York, New York, 10016, United States

Location

Related 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: 10.1016/j.jaad.2017.07.016. Epub 2017 Oct 2.

  PMID: 28982585 RESULT

MeSH Terms

Conditions

Dysplastic Nevus Syndrome; Melanoma

Condition Hierarchy (Ancestors)

Nevus; Nevi and Melanomas; Neoplasms by Histologic Type; Neoplasms; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• David Polsky, MD, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: March 29, 2017
• Study Start: February 25, 2013
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 8, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)