Dysplastic NeviNCT03094273
Prospective Study of 2 mm Margins for the Biopsy of Dysplastic Nevi
An observational study of Dysplastic Nevi, run by NYU Langone Health at 1 site in United States.
Trial summary
Non-interventional study to evaluate the utility of removing Dysplastic Nevi with a defined 2 mm margin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysplastic Nevi
- What is being tested?
- Saucerization biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2013to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: NYU Dermatology Faculty Practice
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Laura & Isaac Perlmutter Cancer Center & NYU Langone Medical Center
New York, New York, 10016
About this study
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.
- Conditions
- Dysplastic Nevi
- Being tested
- Saucerization biopsy
- Keywords
- Melanocytic neoplasm, Biopsy, Saucerization biopsy, Skin lesion
- Medical subject headings
- Dysplastic Nevus Syndrome, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saucerization biopsyProcedure or surgery
2 mm saucerization biopsy of dysplastic nevi
What is being measured
The primary outcome is the main question the study is designed to answer.
Clear margins on the histopathological sections examined after a 2 mm saucerazation biopsy.
2 mm saucerization biopsy
Measured: Up to 1 year
Secondary outcomes (1)
Nevus recurrence rate
To determine the rate of nevus recurrence within 1 year of follow-up
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start25 Feb 2013
- Primary completionJan 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dysplastic NeviStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Polsky, MD, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094273
- Sponsor's protocol ID
- 12-03921
- Status last verified
- May 2019
- First submitted
- 23 Mar 2017
- Last updated
- 8 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of 2 mm Margins for the Biopsy of Dysplastic Nevi
- ClinicalTrials.gov ID
- NCT03094273
- Acronym / sponsor ID
- 12-03921
- Conditions
- Dysplastic Nevi
- Keywords
- Melanocytic neoplasm, Biopsy, Saucerization biopsy, Skin lesion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 25 Feb 2013 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 29 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-interventional study to evaluate the utility of removing Dysplastic Nevi with a defined 2 mm margin.
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NYU Dermatology Faculty Practice
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saucerization biopsy2 mm saucerization biopsy of dysplastic nevi | Procedure or surgery | – |
Primary outcome
Clear margins on the histopathological sections examined after a 2 mm saucerazation biopsy.
Time frame: Up to 1 year
2 mm saucerization biopsy
1 secondary outcome
Nevus recurrence rate
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2019.
- Results publication: PubMed 28982585Terushkin 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.
- Individual participant dataSharing planned: No
Related trials for Dysplastic Nevi
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Sulforaphane for the Prevention of Melanoma in Patients With Multiple Atypical Nevi and a Prior History of Melanoma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Polsky, MD, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysplastic Nevi, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clear margins on the histopathological sections examined after a 2 mm saucerazation biopsy. (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03094273, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2019.