Status:
WITHDRAWN
Mohs and Immunofluorescence for Malignant Melanoma In Situ
Lead Sponsor:
University of Miami
Collaborating Sponsors:
University of Miami Sylvester Comprehensive Cancer Center
Conditions:
Lentigo Maligna
Melanoma In Situ
Eligibility:
All Genders
18+ years
Phase:
NA
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 compar...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02306512
Start Date
June 1 2015
End Date
November 1 2015
Last Update
January 7 2019
Active Locations (2)
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1
Sylvester Comprenhensive Cancer Center
Miami, Florida, United States, 33136
2
University of Miami Hospital dermatology clinics
Miami, Florida, United States, 33136