NCT07258446

PRAME Immunohistochemistry-Guided Slow Mohs Micrographic Surgery for the Treatment of Stage 0 to IIc Cutaneous Melanoma

PRAME (Preferentially Expressed Antigen in Melanoma) Immunohistochemistry Guided Slow-Mohs Micrographic Surgery of Malignant Melanoma: A Pragmatic Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Clinical Stage 0 Cutaneous Melanoma AJCC v8
• Clinical Stage I Cutaneous Melanoma AJCC v8
• Clinical Stage II Cutaneous Melanoma AJCC v8

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Immunohistochemistry Staining Method	Undergo Preferentially Expressed Antigen in Melanoma (PRAME) IHC analysis
PROCEDURE	Mohs Surgery	Undergo slow Mohs micrographic surgery

Timeline

• Start date: 2025-10-24
• Primary completion: 2028-12-01
• Completion: 2033-11-01
• First posted: 2025-12-02
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study