Mohs and Immunofluorescence for Malignant Melanoma In Situ

University of Miami

Status: Withdrawn

Conditions: Lentigo Maligna; Melanoma In Situ

Treatments: Procedure: IF cocktail; Procedure: H&E; Procedure: IF MART-1; Procedure: IHC MART-1

Study type: Interventional

Funder types: Other

Identifiers

NCT02306512

20140210

0000000 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

The aim of this study is to

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female of any race and at least 18 years of age

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

1. Patients under the age of 18
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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Standard vs. IF MART-1

Active Comparator group

Description:

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.

Treatment:

Procedure: IF MART-1

Procedure: IHC MART-1

Procedure: H&E

IF MART-1 versus IF cocktail

Active Comparator group

Description:

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.

Treatment:

Procedure: IF MART-1

Procedure: IF cocktail