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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
University of California Davis Comprehensive Cancer Center
RECRUITING
Sacramento
Time Frame
Start Date: 2025-10-24
Estimated Completion Date: 2033-11-01
Participants
Target number of participants: 36
Treatments
Experimental: Treatment (PRAME IHC-guided SMMS)
Patients undergo standard slow Mohs micrographic surgery with the addition of PRAME IHC analysis per the discretion of the surgeon on study.
Related Therapeutic Areas
Sponsors
Collaborators: National Cancer Institute (NCI)
Leads: University of California, Davis

This content was sourced from clinicaltrials.gov