Prospective Study of 2 mm Margins for the Biopsy of Dysplastic Nevi
Status: | Completed |
---|---|
Conditions: | Hematology, Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery, Hematology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/1/2017 |
Start Date: | February 25, 2013 |
End Date: | March 2016 |
Non-interventional study to evaluate the utility of removing Dysplastic Nevi with a defined
2 mm margin.
2 mm margin.
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.
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.
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).
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