PRAME (Preferentially Expressed Antigen in Melanoma) Immunohistochemistry Guided Slow-Mohs Micrographic Surgery of Malignant Melanoma: A Pragmatic Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Margin status
研究概览
简要总结
This clinical trial tests the addition of preferentially expressed antigen in melanoma (PRAME) immunohistochemical (IHC) staining to standard slow Mohs micrographic surgery (SMMS) for guiding tissue removal in patients with stage 0 to IIc cutaneous melanoma. SMMS is a method of skin cancer removal involving repeated tissue removal and examination under a microscope to ensure the tumor is removed as much as possible while sparing healthy tissue. In SMMS, tissue sections are evaluated to determine whether additional tissue removal is needed. The standard method for evaluating the tissue is by using a specific stain called hematoxylin and eosin (H&E) stains. PRAME is a cancer antigen that is being investigated as a diagnostic marker in certain types of cancer. Adding PRAME IHC analysis to standard SMMS staining methods may improve the accuracy for determining whether additional tissue removal is necessary for patients undergoing SMMS for stage 0 to IIc cutaneous melanoma.
详细描述
PRIMARY OBJECTIVE:
I. To compare the efficacy of PRAME IHC-guided slow Mohs micrographic surgery to routine slow Mohs micrographic surgical practices in patients with melanoma.
SECONDARY OBJECTIVE:
I. To further evaluate the efficacy of PRAME IHC-guided slow Mohs micrographic surgical practices in patients with melanoma.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Scheduled for SMMS of cutaneous melanoma (stage 0 through stage IIc per American Joint Committee on Cancer [AJCC] criteria)
- •Age >= 18 years at time of consent
- •Initial tumor biopsy is PRAME positive or PRAME testing was not done. PRAME testing must be planned if not done
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
排除标准
- •Initial biopsy was PRAME negative
- •Incarcerated persons
- •Patient with severe, active co-morbidity that would preclude a SMMS of cutaneous melanoma (stage 0 through stage IIc per AJCC criteria)
研究组 & 干预措施
Treatment (PRAME IHC-guided SMMS)
Patients undergo standard slow Mohs micrographic surgery with the addition of PRAME IHC analysis per the discretion of the surgeon on study.
干预措施: Mohs Surgery (Procedure)
Treatment (PRAME IHC-guided SMMS)
Patients undergo standard slow Mohs micrographic surgery with the addition of PRAME IHC analysis per the discretion of the surgeon on study.
干预措施: Immunohistochemistry Staining Method (Diagnostic Test)
结局指标
主要结局
Margin status
时间窗: During slow Mohs micrographic surgery (SMMS) procedure
Margin status (positive, negative, or uncertain) will be evaluated from hematoxylin and eosin (H\&E)/SOX-10 + preferentially expressed antigen in melanoma (PRAME) stained sections versus H\&E/SOX-10 stained sections. For PRAME stained sections, margins will be considered positive when \> 75% PRAME+ malignant cells at the tissue margin are observed. The McNemar's test will be used to compare the margin status between the predetermined gold-standard (i.e., H\&E/SOX-10) and H\&E/SOX-10 + PRAME.
次要结局
- Presence of PRAME+ suprabasilar melanocytes in the tissue sections(During SMMS procedure)
- Density of PRAME+ cells(During SMMS procedure)
- Number of stages needed for clear margins(During SMMS procedure)
- Local recurrence of the excised melanoma(Up to 5 years following SMMS)
- Incidence of regional and distant metastases(Up to 5 years following SMMS)