Clinical Trial: Mohs and Immunofluorescence for Malignant Melanoma In Situ
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Mohs Micrographic Surgery for Primary Cutaneous Malignant Melanoma In Situ Using Immunofluorescence
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 Summary:
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.
Sponsor: University of Miami
Current Primary Outcome: IF MART-1 versus Standard H&E and IHC MART-1 [ Time Frame: End of Mohs Surgery, approximately up to 24 hours ]
Original Primary Outcome: Same as current
Current Secondary Outcome: IF cocktail vs IF MART-1 alone [ Time Frame: End of Mohs Surgery, approximately up to 24 hours ]
Original Secondary Outcome: Same as current
Information By: University of Miami
Dates:
Date Received: August 27, 2014
Date Started: June 2015
Date Completion:
Last Updated: December 2, 2015
Last Verified: December 2015
