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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03094273
Recruitment Status : Completed
First Posted : March 29, 2017
Last Update Posted : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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

Condition or disease Intervention/treatment
Dysplastic Nevi Procedure: Saucerization biopsy

Detailed 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.
Study Design
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Study Type : Observational
Actual Enrollment : 138 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Study of 2 mm Margins for the Biopsy of Dysplastic Nevi
Actual Study Start Date : February 25, 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Procedure: Saucerization biopsy
    2 mm saucerization biopsy of dysplastic nevi

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Nevus recurrence rate [ Time Frame: Up to 1 year ]
    To determine the rate of nevus recurrence within 1 year of follow-up


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
NYU Dermatology Faculty Practice
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03094273


Locations
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United States, New York
Laura & Isaac Perlmutter Cancer Center & NYU Langone Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: David Polsky, MD, PhD NYU Langone Health
More Information
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Publications of Results:

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03094273    
Other Study ID Numbers: 12-03921
First Posted: March 29, 2017    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
Melanocytic neoplasm
Biopsy
Saucerization biopsy
Skin lesion
Additional relevant MeSH terms:
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Nevus
Dysplastic Nevus Syndrome
Hyperplasia
Nevi and Melanomas
Neoplasms by Histologic Type
 Neoplasms
Pathologic Processes
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn