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

University of California (UC) Davis

Status: Enrolling

Conditions: Clinical Stage II Cutaneous Melanoma AJCC v8; Clinical Stage 0 Cutaneous Melanoma AJCC v8; Clinical Stage I Cutaneous Melanoma AJCC v8

Treatments: Diagnostic Test: Immunohistochemistry Staining Method; Procedure: Mohs Surgery

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07258446

NCI-2025-08321 (Registry Identifier)

UCDCC324

P30CA093373 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Treatment (PRAME IHC-guided SMMS)

Experimental group

Description:

Patients undergo standard slow Mohs micrographic surgery with the addition of PRAME IHC analysis per the discretion of the surgeon on study.

Treatment:

Procedure: Mohs Surgery

Diagnostic Test: Immunohistochemistry Staining Method