Clinical Stage 0 Cutaneous Melanoma AJCC v8NCT07258446
PRAME Immunohistochemistry-Guided Slow Mohs Micrographic Surgery for the Treatment of Stage 0 to IIc Cutaneous Melanoma
A study testing Immunohistochemistry Staining Method and Mohs Surgery in people with Clinical Stage 0 Cutaneous Melanoma AJCC v8 and Clinical Stage I Cutaneous Melanoma AJCC v8, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical Stage 0 Cutaneous Melanoma AJCC v8, Clinical Stage I Cutaneous Melanoma AJCC v8, Clinical Stage II Cutaneous Melanoma AJCC v8
- What is being tested?
- Immunohistochemistry Staining Method and Mohs Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2025to 1 Nov 2033
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
About this study
Official title: PRAME (Preferentially Expressed Antigen in Melanoma) Immunohistochemistry Guided Slow-Mohs Micrographic Surgery of Malignant Melanoma: A Pragmatic Clinical Trial
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunohistochemistry Staining MethodDiagnostic test
Also called Cell/Tissue, Immunohistochemistry, IHC, Immunohistochemistry, Immunohistochemistry (IHC)
Undergo Preferentially Expressed Antigen in Melanoma (PRAME) IHC analysis
Mohs SurgeryProcedure or surgery
Also called Mohs Micrographic Surgery
Undergo slow Mohs micrographic surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Immunohistochemistry Staining Method; Procedure: Mohs Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During slow Mohs micrographic surgery (SMMS) procedure
Secondary outcomes (5)
Presence of PRAME+ suprabasilar melanocytes in the tissue sections
Will be reported using descriptive statistics, including frequency tables as appropriate.
Measured: During SMMS procedure
Density of PRAME+ cells
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.
Measured: During SMMS procedure
Number of stages needed for clear margins
Will be reported using descriptive statistics, including frequency tables as appropriate.
Measured: During SMMS procedure
Local recurrence of the excised melanoma
Will be reported using descriptive statistics, including frequency tables as appropriate.
Measured: Up to 5 years following SMMS
Incidence of regional and distant metastases
Will be reported using descriptive statistics, including frequency tables as appropriate.
Measured: Up to 5 years following SMMS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start24 Oct 2025
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Nov 2033 (estimated)
Why it stopped: Temporarily suspended due to a significant protocol amendment planned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Stage 0 Cutaneous Melanoma AJCC v8Studies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Daniel B Eisen, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258446
- Sponsor's protocol ID
- UCDCC324
- Other IDs
- NCI-2025-08321, UCDCC324, P30CA093373
- Status last verified
- Apr 2026
- First submitted
- 20 Nov 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRAME (Preferentially Expressed Antigen in Melanoma) Immunohistochemistry Guided Slow-Mohs Micrographic Surgery of Malignant Melanoma: A Pragmatic Clinical Trial
- ClinicalTrials.gov ID
- NCT07258446
- Acronym / sponsor ID
- UCDCC324
- Conditions
- Clinical Stage 0 Cutaneous Melanoma AJCC v8, Clinical Stage I Cutaneous Melanoma AJCC v8, Clinical Stage II Cutaneous Melanoma AJCC v8
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Temporarily suspended due to a significant protocol amendment planned
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Oct 2025 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Nov 2033 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (PRAME IHC-guided SMMS) | Experimental | Diagnostic Test: Immunohistochemistry Staining Method, Procedure: Mohs SurgeryPatients undergo standard slow Mohs micrographic surgery with the addition of PRAME IHC analysis per the discretion of the surgeon on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunohistochemistry Staining MethodAlso: Cell/Tissue, Immunohistochemistry, IHC, Immunohistochemistry, Immunohistochemistry (IHC)Undergo Preferentially Expressed Antigen in Melanoma (PRAME) IHC analysis | Diagnostic test | Treatment (PRAME IHC-guided SMMS) |
| Mohs SurgeryAlso: Mohs Micrographic SurgeryUndergo slow Mohs micrographic surgery | Procedure or surgery | Treatment (PRAME IHC-guided SMMS) |
Primary outcome
Margin status
Time frame: During slow Mohs micrographic surgery (SMMS) procedure
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.
5 secondary outcomes
Presence of PRAME+ suprabasilar melanocytes in the tissue sections
Time frame: During SMMS procedure
Density of PRAME+ cells
Time frame: During SMMS procedure
Number of stages needed for clear margins
Time frame: During SMMS procedure
Local recurrence of the excised melanoma
Time frame: Up to 5 years following SMMS
Incidence of regional and distant metastases
Time frame: Up to 5 years following SMMS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel B Eisen principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunohistochemistry Staining Method and Mohs Surgery in people with Clinical Stage 0 Cutaneous Melanoma AJCC v8 and Clinical Stage I Cutaneous Melanoma AJCC v8, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Margin status (time frame: During slow Mohs micrographic surgery (SMMS) procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.