Mohs and Immunofluorescence for Malignant Melanoma In Situ
- Conditions
- Lentigo MalignaMelanoma In Situ
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
-
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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- 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
Sylvester Comprenhensive Cancer Center🇺🇸Miami, Florida, United States