ClinicalTrials.gg
CompletedNCT03094273Updated May 8, 2019

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

An observational study in Dysplastic Nevi, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-08.

Sponsored by NYU Langone Health · Observational

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
138
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 17 studies in Dysplastic Nevus Syndrome with a site in United States — 5 open to participants now, 6 under way, 1 of them phase 3. Dysplastic Nevus Syndrome · United States.

Enrollment
9th of 11
138 · median 265
Started
2013
the only one that year
Observational
11 of 17
3 open now
Registered
9th of 17
by date
Lead sponsor
1 of 17
NYU Langone Health

Among the 17 studies in Dysplastic Nevus Syndrome with a site in United States, this one is the 9th largest by enrollment of the 11 observational ones that give a count, is the only one that started in 2013, is one of 11 observational ones, and was the 9th registered.

Dysplastic Nevus Syndrome

24 studies on the registry are indexed under Dysplastic Nevus Syndrome; 7 are open to participants now.

Browse Dysplastic Nevus Syndrome studies →

Open to participants now

5 of the 17 studies in Dysplastic Nevus Syndrome with a site in United States are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 6 Dysplastic Nevus Syndrome studies recruiting now, 4 set no upper age limit and none stop at 75 or younger; 1 takes children under 18; 1 takes healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 17 studies in Dysplastic Nevus Syndrome with a site in United States, or all of them as a file.
02

Study summary

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

Read the 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.

03

Conditions studied

  • Dysplastic Nevi

Keywords

  • Melanocytic neoplasm
  • Biopsy
  • Saucerization biopsy
  • Skin lesion
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

NYU Dermatology Faculty Practice

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .
  • 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 .

Exclusion criteria

Exclusion Criteria:

  • Patients who are less than 18 years of age.
  • Patients who are unable to provide .
  • Lesions for which a saucerization 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).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
138 participants (actual)
Patient registry
No

Interventions

  • ProcedureSaucerization biopsy

    2 mm saucerization biopsy of dysplastic nevi

06

What researchers measure

Primary outcomes

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

    2 mm saucerization biopsy

    Time frame: Up to 1 year

Secondary outcomes

  1. Nevus recurrence rate

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

    Time frame: Up to 1 year

07

Study locations

1 site
  • Laura & Isaac Perlmutter Cancer Center & NYU Langone Medical Center
    New York, New York 10016, United States
08

References and documents

Publications

  • 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. PubMed 28982585 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2013 to primary completion in Jan 2016, 35 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 23, 2017
First posted
Mar 29, 2017
StartActual
Feb 25, 2013
Primary completionActual
Jan 2016
CompletionActual
Mar 2016
Last update
May 8, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03094273
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Mar 29, 2017
Start date
Feb 25, 2013
Primary completion
Jan 2016
Completion
Mar 2016
Last update
May 8, 2019

Study contacts

David Polsky, MD, PhD
principal investigator · NYU Langone Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion