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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-08321 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| UCDCC324 | Other Identifier | University of California Davis Comprehensive Cancer Center | |
| P30CA093373 | U.S. NIH Grant/Contract | View source |
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Temporarily suspended due to a significant protocol amendment planned
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunohistochemistry Staining Method | Diagnostic Test | Undergo Preferentially Expressed Antigen in Melanoma (PRAME) IHC analysis |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of PRAME+ suprabasilar melanocytes in the tissue sections | Will be reported using descriptive statistics, including frequency tables as appropriate. | During SMMS procedure |
| Density of PRAME+ cells |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel B Eisen | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | United States |
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| Mohs Surgery | Procedure | Undergo slow Mohs micrographic surgery |
|
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Will be reported as a quartile system (0% positive, 1-25% positive, 26-50% positive, 51-75% positive and > 75% positive). Will be reported using descriptive statistics, including frequency tables as appropriate.
| During SMMS procedure |
| Number of stages needed for clear margins | Will be reported using descriptive statistics, including frequency tables as appropriate. | During SMMS procedure |
| Local recurrence of the excised melanoma | Will be reported using descriptive statistics, including frequency tables as appropriate. | Up to 5 years following SMMS |
| Incidence of regional and distant metastases | Will be reported using descriptive statistics, including frequency tables as appropriate. | Up to 5 years following SMMS |
| ID | Term |
|---|---|
| D007150 | Immunohistochemistry |
| D015580 | Mohs Surgery |
| ID | Term |
|---|---|
| D006651 | Histocytochemistry |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
| D008866 | Microsurgery |
| D013514 | Surgical Procedures, Operative |
| D062109 | Dermatologic Surgical Procedures |
| D019651 | Plastic Surgery Procedures |
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