An interventional study of Wide Local Excision in Cutaneous Melanoma, Stage II, Cutaneous Melanoma and Acral Melanoma, sponsored by University of Nebraska. Not yet recruiting at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by University of Nebraska · Not applicable, Interventional, and Diagnostic
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:
Researchers will compare standard breadloafing (control) arm to CPDMA (experimental) arm.
Participants will:
3,073 studies on the registry are indexed under Melanoma; 529 are open to participants now.
This study's planned enrollment of 282 is above the median of 38 across 2,400 interventional studies indexed under Melanoma.
Browse Melanoma studies →University of Nebraska is the lead sponsor of 495 studies on the registry; 68 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 52 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Control Arm
Diagnostic Test: Wide Local Excision
Experimental Arm
Diagnostic Test: Wide Local Excision
Wide Local Excision
Rate of positive peripheral margins
Tumor present at or near inked margin
Time frame: 1 Month
Local recurrence rate
In situ or invasive melanoma within 2 cm of the scar from treatment of the primary tumor
Time frame: 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
Time frame: 2 months post-WLE, documented at 4-month post-WLE visit
Pathology turnaround time
From WLE date to final pathology report date
Time frame: Post-pathology report or 4-month follow-up
Pathology resource utilization
Number of tissue blocks and slides used
Time frame: Post-pathology report or 4-month follow-up
Pathologist time
Start of specimen review to end of specimen review
Time frame: 1 Month
Technician time
Opening container to closing the block
Time frame: 1 Month
Cost per case
Total amount billed
Time frame: 2 years post-WLE
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2029, 36 months later.
Of 196 non-industry interventional studies with no phase under Melanoma, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 64. This study's planned 36 months is below that.
Counting every sponsor, half of 202 studies reached it within 39 months; a quarter within 21 and three quarters within 62.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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