Mohs and Immunofluorescence for Malignant Melanoma In Situ
NCT ID: NCT02306512
Last Updated: 2019-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2015-06-30
2015-11-30
Brief Summary
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Detailed Description
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1. Determine the feasibility of using melanocytic markers such as Melanoma antigen recognized by T cells 1 (MART-1) with fluorescence to clear surgical margins when compared to conventional MART-1 immunohistochemistry (IHC) in the setting of MMS for LM (lentigo maligna type melanoma in situ).
2. Compare the use of a cocktail of immunofluorescent markers such as, but not limited to, Sex-determining Region Y (SRY)-box 10 (SOX10), human melanoma black 45 (HMB-45), and Kiel-67 (Ki-67) to sections only stained with fluorescent MART-1 alone.
3. Explore the value of using other combinations of immunofluorescent markers such as S-100 with Microphthalmia-associated transcription factor (MiTF), Nestin with Ki-67, and HMB-45 with Lamin.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Standard vs. IF MART-1
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.
H&E
Sample will be stained with H\&E according to standard procedures
IHC MART-1
Samples will be stained with immunohistochemistry antibody: MART-1 according to standard procedures.
IF MART-1
Samples will be stained with immunofluorescence antibody: MART-1 according to standard procedures.
IF MART-1 versus IF cocktail
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.
IF MART-1
Samples will be stained with immunofluorescence antibody: MART-1 according to standard procedures.
IF cocktail
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.
Interventions
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H&E
Sample will be stained with H\&E according to standard procedures
IHC MART-1
Samples will be stained with immunohistochemistry antibody: MART-1 according to standard procedures.
IF MART-1
Samples will be stained with immunofluorescence antibody: MART-1 according to standard procedures.
IF cocktail
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.
Eligibility Criteria
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Inclusion Criteria
2. Patient with biopsied proven Lentigo maligna (LM) in situ
3. Patient meets criteria for Mohs Micrographic Surgery (MMS)
1. The cancer is large
2. The edges of the cancer (clinical margins) cannot be clearly defined
3. Prior treatment has failed, i.e. recurrent tumor
4. The cancer is located in a cosmetically sensitive or functionally critical area of the body (such as eyelids, nose, ears, lips, fingers, toes, and genitals)
5. The histologic pattern of the cancer is aggressive
6. The patient is immunosuppressed
4. Patient with biopsied proven LM in situ located on an anatomic areas appropriate for MMS:
1. Area H: ''Mask areas'' of face (central face, eyelids \[including inner/outer canthi\], eyebrows, nose, lips \[cutaneous/mucosal/vermillion\], chin, ear and periauricular skin/sulci, temple), genitalia (including perineal and perianal), hands, feet, nail units, ankles, and nipples/areola.
2. Area M: Cheeks, forehead, scalp, neck, jawline, pretibial surface.
3. Area L: Trunk and extremities (excluding pretibial surface, hands, feet, nail units, and ankles).
5. Patient able to tolerate surgery
6. Patient is able to comply with appointments including follow-up appointments
7. Ability to understand and willingness to sign a written informed consent document
Exclusion Criteria
2. Patient does not meet criteria for MMS or has LM located in areas that are not accessible with MMS
3. Patient with previously diagnosed invasive LM
4. Patients unable to comply with follow-up
5. Adults unable to consent
6. Pregnant women
7. Prisoners
18 Years
ALL
No
Sponsors
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University of Miami Sylvester Comprehensive Cancer Center
OTHER
University of Miami
OTHER
Responsible Party
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Robert S. Kirsner
Professor, Vice Chairman Department of Dermatology & Cutaneous Surgery
Principal Investigators
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James Grichnik, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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Sylvester Comprenhensive Cancer Center
Miami, Florida, United States
University of Miami Hospital dermatology clinics
Miami, Florida, United States
Countries
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Other Identifiers
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0000000
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
20140210
Identifier Type: -
Identifier Source: org_study_id
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