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

NCT07258446 | Suspended DMC FDA Device

• 3 other identifiers: UCDCC324NCI-2025-08321P30CA093373
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Margin 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.

  During slow Mohs micrographic surgery (SMMS) procedure

Secondary Outcomes (5)

• 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

Study Arms (1)

Treatment (PRAME IHC-guided SMMS)

EXPERIMENTAL

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

Diagnostic Test: Immunohistochemistry Staining Method; Procedure: Mohs Surgery

Interventions

Immunohistochemistry Staining Method DIAGNOSTIC_TEST

Undergo Preferentially Expressed Antigen in Melanoma (PRAME) IHC analysis

Also known as: Cell/Tissue, Immunohistochemistry, IHC, Immunohistochemistry, Immunohistochemistry (IHC), PRAME, Preferentially Expressed Antigen in Melanoma

Treatment (PRAME IHC-guided SMMS)

Mohs Surgery PROCEDURE

Undergo slow Mohs micrographic surgery

Also known as: Mohs Micrographic Surgery

Treatment (PRAME IHC-guided SMMS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Davis: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Interventions

Immunohistochemistry; Mohs Surgery

Intervention Hierarchy (Ancestors)

Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques; Microsurgery; Surgical Procedures, Operative; Dermatologic Surgical Procedures; Plastic Surgery Procedures

Study Officials

• Daniel B Eisen

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 2, 2025
• Study Start: October 24, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): November 1, 2033
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

US (1)