PRAME Immunohistochemistry-Guided Slow Mohs Micrographic Surgery for the Treatment of Stage 0 to IIc Cutaneous Melanoma
NCT07258446 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2026-05-01
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
Interventions
- DIAGNOSTIC_TEST
-
Immunohistochemistry Staining Method
Undergo Preferentially Expressed Antigen in Melanoma (PRAME) IHC analysis
- PROCEDURE
-
Mohs Surgery
Undergo slow Mohs micrographic surgery
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
University of California, Davis
lead OTHER
Principal Investigators
-
Daniel B Eisen · University of California, Davis
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-24
- Primary Completion
- 2028-12-01
- Completion
- 2033-11-01
- FDA Device
- Yes
Countries
- United States
Study Locations
More Related Trials
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT07253649 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT02579486 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT07275944 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT06924866 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT00764452 ·Status: WITHHELD
-
Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury
NCT07264868 ·Status: RECRUITING ·Phase: NA
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT02089646 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT07224984 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT07339046 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT04680546 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT01733264 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT07216625 ·Status: WITHHELD
-
The FINTEPLA as an Anti-SUDEP Therapy in Dravet Syndrome Project
NCT07112365 ·Status: NOT_YET_RECRUITING ·Phase: PHASE4
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT01062464 ·Status: WITHHELD
-
EASEE® System Pivotal Study for the United States of America
NCT07301346 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT07296432 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT03124264 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT00863486 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT02548429 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT01258400 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT07219225 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT02680964 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT05869448 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT03125044 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT07269431 ·Status: WITHHELD