RecruitingNot ApplicableNCT07258446

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

Sponsor

University of California, Davis

Enrollment

36 participants

Start Date

Oct 24, 2025

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates whether using a protein called PRAME — detected on a melanoma biopsy — can help guide a very precise type of skin cancer surgery called Slow Mohs Micrographic Surgery (SMMS), which removes thin layers of skin and checks them under the microscope to ensure all cancer cells are removed. **You may be eligible if...** - You are 18 or older - You have cutaneous melanoma (skin melanoma) at an early stage (stage 0 to IIc) and are scheduled for SMMS - Your initial tumor biopsy was PRAME positive, or PRAME testing was not yet done (but is planned) **You may NOT be eligible if...** - Your initial biopsy tested PRAME negative - You have severe medical conditions that prevent you from undergoing SMMS - You are unable or unwilling to comply with study follow-up Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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