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.
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: Patients undergo standard slow Mohs micrographic surgery with the addition of PRAME IHC analysis per the discretion of the surgeon on study. After completion of study treatment, patients are followed up every 6 months for up to 5 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Undergo Preferentially Expressed Antigen in Melanoma (PRAME) IHC analysis
Undergo slow Mohs micrographic surgery
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
RECRUITINGMargin status
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.
Time frame: During slow Mohs micrographic surgery (SMMS) procedure
Presence of PRAME+ suprabasilar melanocytes in the tissue sections
Will be reported using descriptive statistics, including frequency tables as appropriate.
Time frame: During SMMS procedure
Density of PRAME+ cells
Will be reported as a quartile system (0% positive, 1-25% positive, 26-50% positive, 51-75% positive and \> 75% positive). Will be reported using descriptive statistics, including frequency tables as appropriate.
Time frame: During SMMS procedure
Number of stages needed for clear margins
Will be reported using descriptive statistics, including frequency tables as appropriate.
Time frame: During SMMS procedure
Local recurrence of the excised melanoma
Will be reported using descriptive statistics, including frequency tables as appropriate.
Time frame: Up to 5 years following SMMS
Incidence of regional and distant metastases
Will be reported using descriptive statistics, including frequency tables as appropriate.
Time frame: Up to 5 years following SMMS
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.