Mohs and Immunofluorescence for Malignant Melanoma In Situ

Not Applicable

Withdrawn

• Conditions: Lentigo Maligna; Melanoma In Situ
• Interventions: Procedure: IF MART-1; Procedure: H&E; Procedure: IHC MART-1; Procedure: IF cocktail

• Registration Number: NCT02306512
• Lead Sponsor: University of Miami

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2014-08-27
• Study First Submitted QC: 2014-11-30
• Study First Posted: 2014-12-03
• Study Start: 2015-06
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-03
• Last Update Posted: 2019-01-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard vs. IF MART-1	IHC 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.
IF MART-1 versus IF cocktail	IF MART-1	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.
Standard vs. IF MART-1	H&E	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.
Standard vs. IF MART-1	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.
IF MART-1 versus IF cocktail	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.

Primary Outcome Measures

Name	Time	Method
IF MART-1 versus Standard H&E and IHC MART-1	End of Mohs Surgery, approximately up to 24 hours	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

Secondary Outcome Measures

Name	Time	Method
IF cocktail vs IF MART-1 alone	End of Mohs Surgery, approximately up to 24 hours	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

Trial Locations

Locations (2)

Sylvester Comprenhensive Cancer Center; 🇺🇸 Miami, Florida, United States

University of Miami Hospital dermatology clinics; 🇺🇸 Miami, Florida, United States