Mohs Micrographic Surgery for Primary Cutaneous Malignant Melanoma In Situ Using Immunofluorescence
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- IF MART-1 versus Standard H&E and IHC MART-1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Standard vs. IF MART-1
Samples removed with MMS within the first 3 mm margin from the tumor will be the first section. They will be processed as a conventional H&E frozen section and section stained with IHC MART-1. Samples removed with MMS within 3-6 mm from tumor margin will be the second section. They will be processed with fluorescent MART-1 antibodies. Based on the pre-defined characteristics MMS surgeon will evaluate each MART-1 immunofluorescent section as "no evident melanoma" or "possible melanoma" or "present melanoma". Dermatopathologist will secondarily review each section scoring them in the same manner. If standard H&E, IHC, or immunofluorescence is recorded as "present melanoma" or "possible melanoma" a third section from 6-9mm will have the same procedure described before.
干预措施: H&E (Procedure)
Standard vs. IF MART-1
Samples removed with MMS within the first 3 mm margin from the tumor will be the first section. They will be processed as a conventional H&E frozen section and section stained with IHC MART-1. Samples removed with MMS within 3-6 mm from tumor margin will be the second section. They will be processed with fluorescent MART-1 antibodies. Based on the pre-defined characteristics MMS surgeon will evaluate each MART-1 immunofluorescent section as "no evident melanoma" or "possible melanoma" or "present melanoma". Dermatopathologist will secondarily review each section scoring them in the same manner. If standard H&E, IHC, or immunofluorescence is recorded as "present melanoma" or "possible melanoma" a third section from 6-9mm will have the same procedure described before.
干预措施: IHC MART-1 (Procedure)
Standard vs. IF MART-1
Samples removed with MMS within the first 3 mm margin from the tumor will be the first section. They will be processed as a conventional H&E frozen section and section stained with IHC MART-1. Samples removed with MMS within 3-6 mm from tumor margin will be the second section. They will be processed with fluorescent MART-1 antibodies. Based on the pre-defined characteristics MMS surgeon will evaluate each MART-1 immunofluorescent section as "no evident melanoma" or "possible melanoma" or "present melanoma". Dermatopathologist will secondarily review each section scoring them in the same manner. If standard H&E, IHC, or immunofluorescence is recorded as "present melanoma" or "possible melanoma" a third section from 6-9mm will have the same procedure described before.
干预措施: IF MART-1 (Procedure)
IF MART-1 versus IF cocktail
In the second arm of the study, assuming that immunofluorescence with MART-1 proves to be superior or at least equivocal to regular MART-1 IHC, the same method will be applied, but the control sections will be stained with fluorescent MART-1 antibodies and compared to a section stained with a cocktail of fluorescent melanocytic antibodies.
干预措施: IF MART-1 (Procedure)
IF MART-1 versus IF cocktail
In the second arm of the study, assuming that immunofluorescence with MART-1 proves to be superior or at least equivocal to regular MART-1 IHC, the same method will be applied, but the control sections will be stained with fluorescent MART-1 antibodies and compared to a section stained with a cocktail of fluorescent melanocytic antibodies.
干预措施: IF cocktail (Procedure)
结局指标
主要结局
IF MART-1 versus Standard H&E and IHC MART-1
时间窗: 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
次要结局
- IF cocktail vs IF MART-1 alone(End of Mohs Surgery, approximately up to 24 hours)
研究者
Robert S. Kirsner
Professor, Vice Chairman Department of Dermatology & Cutaneous Surgery
University of Miami