Melanoma Clinical Trial

Mohs and Immunofluorescence for Malignant Melanoma In Situ

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.

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Full Description

The aim of this study is to

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).
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.
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.

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Eligibility Criteria

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)

The cancer is large
The edges of the cancer (clinical margins) cannot be clearly defined
Prior treatment has failed, i.e. recurrent tumor
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)
The histologic pattern of the cancer is aggressive
The patient is immunosuppressed

Patient with biopsied proven LM in situ located on an anatomic areas appropriate for MMS:

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.
Area M: Cheeks, forehead, scalp, neck, jawline, pretibial surface.
Area L: Trunk and extremities (excluding pretibial surface, hands, feet, nail units, and ankles).
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:

Patients under the age of 18
Patient does not meet criteria for MMS or has LM located in areas that are not accessible with MMS
Patient with previously diagnosed invasive LM
Patients unable to comply with follow-up
Adults unable to consent
Pregnant women
Prisoners

Study is for people with:

Melanoma

Study ID:

NCT02306512

Recruitment Status:

Withdrawn

Sponsor:

University of Miami

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There is 1 Location for this study

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Sylvester Comprenhensive Cancer Center
Miami Florida, 33136, United States
University of Miami Hospital dermatology clinics
Miami Florida, 33136, United States

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Study ID:

NCT02306512

Recruitment Status:

Withdrawn

Sponsor:


University of Miami

How clear is this clinincal trial information?

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