Trials / Withdrawn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- Withdrawn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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | H&E | Sample will be stained with H\&E according to standard procedures |
| PROCEDURE | IHC MART-1 | Samples will be stained with immunohistochemistry antibody: MART-1 according to standard procedures. |
| PROCEDURE | IF MART-1 | Samples will be stained with immunofluorescence antibody: MART-1 according to standard procedures. |
| PROCEDURE | IF cocktail | The 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.