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

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a study on Skin Cancer/Melanoma

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Sacramento, California
Dates
study started
study ends around
Principal Investigator
by Daniel B Eisen
Headshot of Daniel B Eisen
Daniel B Eisen

Description

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.

Official Title

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

Details

PRIMARY OBJECTIVE:

  1. 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:

  1. 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.

Keywords

Clinical Stage 0 Cutaneous Melanoma AJCC v8, Clinical Stage I Cutaneous Melanoma AJCC v8, Clinical Stage II Cutaneous Melanoma AJCC v8, Immunohistochemistry, Mohs Surgery, Immunohistochemistry Staining Method

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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)

Location

  • University of California Davis Comprehensive Cancer Center accepting new patients
    Sacramento California 95817 United States

Lead Scientist at UC Davis

  • Daniel B Eisen
    Professor, Med: Dermatology, School of Medicine. Authored (or co-authored) 146 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
Links
Sign up for this study
ID
NCT07258446
Study Type
Interventional
Participants
Expecting 36 study participants
Last Updated
Contact us about this trial