Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT02306512

Mohs and Immunofluorescence for Malignant Melanoma In Situ

Mohs Micrographic Surgery for Primary Cutaneous Malignant Melanoma In Situ Using Immunofluorescence

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
University of Miami · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREH&ESample will be stained with H\&E according to standard procedures
PROCEDUREIHC MART-1Samples will be stained with immunohistochemistry antibody: MART-1 according to standard procedures.
PROCEDUREIF MART-1Samples will be stained with immunofluorescence antibody: MART-1 according to standard procedures.
PROCEDUREIF cocktailThe fluorescent primary antibodies may include HMB-45, SOX10, Ki-67 and MART-1. However other markers will be considered to make the most visually remarkable cocktail; these may include S-100, MiTF, lamin and nestin. Primary antibodies will be tagged with secondary antibodies labeled with fluorescent signals. A fluorescent organelle stain and/or 4',6-diamidine-2-phenylindol (DAPI) may also be used to enhance cellular architecture.

Timeline

Start date
2015-06-01
Primary completion
2015-11-01
Completion
2015-11-01
First posted
2014-12-03
Last updated
2019-01-07

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02306512. Inclusion in this directory is not an endorsement.