Cutaneous Melanoma, Stage IINCT07869381
Trial Comparing CPDMA Versus Standard Breadloafing in WLE Specimens of Stage 1-II Cutaneous Melanoma
A study testing Wide Local Excision in people with Cutaneous Melanoma, Stage II and Cutaneous Melanoma, run by University of Nebraska at 1 site in United States.
Trial summary
The primary goal of this clinical trial is to is to compare the rate of positive peripheral margins in wide local excision (WLE) performed to allow for comprehensive peripheral and deep margin assessment (CPDMA) assessment versus WLE performed with the intent of standard breadloafing of stage I-II cutaneous melanoma… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cutaneous Melanoma, Stage II, Cutaneous Melanoma, Acral Melanoma
- What is being tested?
- Wide Local Excision
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Dec 2026to 24 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥19 years
- Histologically confirmed clinical Stage I or II cutaneous melanoma, inclusive of acral melanoma
- Candidate for guideline (NCCN) concordant wide local excision
- Able to provide informed consent
Who cannot join
- Prior wide local excision of the lesion
- History of melanoma
- Melanoma lesions at more than one site
- Prior radiation therapy to the site
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
IIT Office, 402-559-4596, iitoffice@unmc.edu
Joshua Mammen
About this study
Official title: A Randomized Controlled Trial Comparing Comprehensive Peripheral Deep Margin Assessment Versus Standard Breadloafing in Wide Local Excision Specimens of Clinical Stage I-II Cutaneous Melanoma
The primary goal of this clinical trial is to is to compare the rate of positive peripheral margins in wide local excision (WLE) performed to allow for comprehensive peripheral and deep margin assessment (CPDMA) assessment versus WLE performed with the intent of standard breadloafing of stage I-II cutaneous melanoma specimens. Secondary aims are to compare local recurrence at 1 and 2 years, the rate of re-excision due to positive margins, pathology turnaround time, pathology resource utilization, and cost per case between the two assessment methods. The main questions it aims to answer are:
- Does WLE performed to allow for CPDMA have a higher rate of positive peripheral margins than wide local excision performed with the intent of standard breadloafing?
- Will more complete positive margin detection support more appropriate re-excision and lower local recurrence over two years?
- Does CPDMA require greater pathology resource utilization and longer turnaround time than breadloafing?
Read more
Researchers will compare standard breadloafing (control) arm to CPDMA (experimental) arm.
Participants will:
- Undergo WLE.
- Attend a follow-up visit at 4 months.
- Being tested
- Wide Local Excision
- Keywords
- Cutaneous Melanoma, Breadloafing, CPDMA, Wide Local Excision
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wide Local ExcisionDiagnostic test
Wide Local Excision
| Study group | Role | What they receive |
|---|---|---|
| Standard Breadloafing | Active comparator | Control Arm Receives: Diagnostic Test: Wide Local Excision |
| Comprehensive Peripheral and Deep Margin Assessment | Experimental | Experimental Arm Receives: Diagnostic Test: Wide Local Excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of positive peripheral margins
Tumor present at or near inked margin
Measured: 1 Month
Secondary outcomes (7)
Local recurrence rate
In situ or invasive melanoma within 2 cm of the scar from treatment of the primary tumor
Measured: 1 and 2 years post-WLE
Re-excision rate
Need for repeat surgical intervention of the primary site to attain additional margins within 60 days of the index surgery
Measured: 2 months post-WLE, documented at 4-month post-WLE visit
Pathology turnaround time
From WLE date to final pathology report date
Measured: Post-pathology report or 4-month follow-up
Pathology resource utilization
Number of tissue blocks and slides used
Measured: Post-pathology report or 4-month follow-up
Pathologist time
Start of specimen review to end of specimen review
Measured: 1 Month
Technician time
Opening container to closing the block
Measured: 1 Month
Cost per case
Total amount billed
Measured: 2 years post-WLE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start24 Dec 2026 (estimated)
- Primary completion24 Dec 2029 (estimated)
- Study completion24 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Melanoma, Stage IIStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 282 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua Mammen, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869381
- Sponsor's protocol ID
- CPMABREAD
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Comprehensive Peripheral Deep Margin Assessment Versus Standard Breadloafing in Wide Local Excision Specimens of Clinical Stage I-II Cutaneous Melanoma
- ClinicalTrials.gov ID
- NCT07869381
- Acronym / sponsor ID
- CPMABREAD
- Keywords
- Cutaneous Melanoma, Breadloafing, CPDMA, Wide Local Excision
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 282 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 24 Dec 2026 (estimated)
- Primary completion
- 24 Dec 2029 (estimated)
- Study completion
- 24 Dec 2031 (estimated)
- First posted
- 9 Oct 2026 (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.
The primary goal of this clinical trial is to is to compare the rate of positive peripheral margins in wide local excision (WLE) performed to allow for comprehensive peripheral and deep margin assessment (CPDMA) assessment versus WLE performed with the intent of standard breadloafing of stage I-II cutaneous melanoma specimens. Secondary aims are to compare local recurrence at 1 and 2 years, the rate of re-excision due to positive margins, pathology turnaround time, pathology resource utilization, and cost per case between the two assessment methods. The main questions it aims to answer are:
- Does WLE performed to allow for CPDMA have a higher rate of positive peripheral margins than wide local excision performed with the intent of standard breadloafing?
- Will more complete positive margin detection support more appropriate re-excision and lower local recurrence over two years?
- Does CPDMA require greater pathology resource utilization and longer turnaround time than breadloafing?
Researchers will compare standard breadloafing (control) arm to CPDMA (experimental) arm.
Participants will:
- Undergo WLE.
- Attend a follow-up visit at 4 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Breadloafing | Active comparator | Diagnostic Test: Wide Local ExcisionControl Arm |
| Comprehensive Peripheral and Deep Margin Assessment | Experimental | Diagnostic Test: Wide Local ExcisionExperimental Arm |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥19 years
- Histologically confirmed clinical Stage I or II cutaneous melanoma, inclusive of acral melanoma
- Candidate for guideline (NCCN) concordant wide local excision
- Able to provide informed consent
Key exclusion criteria (5 listed)
- Prior wide local excision of the lesion
- History of melanoma
- Melanoma lesions at more than one site
- Prior radiation therapy to the site
- Pregnancy or lactation
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 |
|---|---|---|
| Wide Local ExcisionWide Local Excision | Diagnostic test | Comprehensive Peripheral and Deep Margin Assessment, Standard Breadloafing |
Primary outcome
Rate of positive peripheral margins
Time frame: 1 Month
Tumor present at or near inked margin
7 secondary outcomes
Local recurrence rate
Time frame: 1 and 2 years post-WLE
Re-excision rate
Time frame: 2 months post-WLE, documented at 4-month post-WLE visit
Pathology turnaround time
Time frame: Post-pathology report or 4-month follow-up
Pathology resource utilization
Time frame: Post-pathology report or 4-month follow-up
Pathologist time
Time frame: 1 Month
Technician time
Time frame: 1 Month
Cost per case
Time frame: 2 years post-WLE
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Joshua Mammen principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wide Local Excision in people with Cutaneous Melanoma, Stage II and Cutaneous Melanoma, run by University of Nebraska 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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 9 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact IIT Office (402-559-4596, iitoffice@unmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of positive peripheral margins (time frame: 1 Month). 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 9 Oct 2026.