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| ID | Type | Description | Link |
|---|---|---|---|
| 0000000 | Other Grant/Funding Number | Sylvester Cancer Comprenhensive Center |
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PI is leaving the University of Miami
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| Name | Class |
|---|---|
| University of Miami Sylvester Comprehensive Cancer Center | OTHER |
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The purpose of this study is to determine if immunofluorescence (IF) can effectively identify features of malignant melanoma in situ, on sun-damaged skin, in the setting of Mohs Micrographic Surgery.
The aim of this study is to
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard vs. IF MART-1 | Active Comparator | Samples removed with MMS within the first 3 mm margin from the tumor will be the first section. They will be processed as a conventional H&E frozen section and section stained with IHC MART-1. Samples removed with MMS within 3-6 mm from tumor margin will be the second section. They will be processed with fluorescent MART-1 antibodies. Based on the pre-defined characteristics MMS surgeon will evaluate each MART-1 immunofluorescent section as "no evident melanoma" or "possible melanoma" or "present melanoma". Dermatopathologist will secondarily review each section scoring them in the same manner. If standard H&E, IHC, or immunofluorescence is recorded as "present melanoma" or "possible melanoma" a third section from 6-9mm will have the same procedure described before. |
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| IF MART-1 versus IF cocktail | Active Comparator | In the second arm of the study, assuming that immunofluorescence with MART-1 proves to be superior or at least equivocal to regular MART-1 IHC, the same method will be applied, but the control sections will be stained with fluorescent MART-1 antibodies and compared to a section stained with a cocktail of fluorescent melanocytic antibodies. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| H&E | Procedure | Sample will be stained with H&E according to standard procedures |
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| Measure | Description | Time Frame |
|---|---|---|
| IF MART-1 versus Standard H&E and IHC MART-1 | Comparison of the number of high power fields containing melanoma in situ with IF Mart-1 vs. standard H&E and IHC Mart-1 when evaluating margins during MMS | End of Mohs Surgery, approximately up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| IF cocktail vs IF MART-1 alone | Comparison of the number of high-power fields containing melanoma in situ with IF cocktail vs. IF Mart-1 alone when evaluating margins during MMS | End of Mohs Surgery, approximately up to 24 hours |
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Inclusion Criteria:
Male or female of any race and at least 18 years of age
Patient with biopsied proven Lentigo maligna (LM) in situ
Patient meets criteria for Mohs Micrographic Surgery (MMS)
Patient with biopsied proven LM in situ located on an anatomic areas appropriate for MMS:
Patient able to tolerate surgery
Patient is able to comply with appointments including follow-up appointments
Ability to understand and willingness to sign a written informed consent document
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Grichnik, MD, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sylvester Comprenhensive Cancer Center | Miami | Florida | 33136 | United States | ||
| University of Miami Hospital dermatology clinics |
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| ID | Term |
|---|---|
| D018327 | Hutchinson's Melanotic Freckle |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| IHC MART-1 |
| Procedure |
Samples will be stained with immunohistochemistry antibody: MART-1 according to standard procedures. |
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| IF MART-1 | Procedure | Samples will be stained with immunofluorescence antibody: MART-1 according to standard procedures. |
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| IF cocktail | Procedure | The fluorescent primary antibodies may include HMB-45, SOX10, Ki-67 and MART-1. However other markers will be considered to make the most visually remarkable cocktail; these may include S-100, MiTF, lamin and nestin. Primary antibodies will be tagged with secondary antibodies labeled with fluorescent signals. A fluorescent organelle stain and/or 4',6-diamidine-2-phenylindol (DAPI) may also be used to enhance cellular architecture. |
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| Miami |
| Florida |
| 33136 |
| United States |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |