[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659747":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":39,"studyPopulation":39,"armGroups":46,"interventions":58,"overallOfficials":63,"centralContacts":67,"locations":73,"responsibleParty":90,"collaborators":39,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":39,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":39,"enrollmentInfo":101,"targetDuration":39,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":112,"overallStatus":115,"whyStopped":39,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"University of Nebraska","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":39},[9],{"measure":10,"description":11,"timeFrame":12},"Rate of positive peripheral margins","Tumor present at or near inked margin","1 Month",[14,18,22,26,29,32,35],{"measure":15,"description":16,"timeFrame":17},"Local recurrence rate","In situ or invasive melanoma within 2 cm of the scar from treatment of the primary tumor","1 and 2 years post-WLE",{"measure":19,"description":20,"timeFrame":21},"Re-excision rate","Need for repeat surgical intervention of the primary site to attain additional margins within 60 days of the index surgery","2 months post-WLE, documented at 4-month post-WLE visit",{"measure":23,"description":24,"timeFrame":25},"Pathology turnaround time","From WLE date to final pathology report date","Post-pathology report or 4-month follow-up",{"measure":27,"description":28,"timeFrame":25},"Pathology resource utilization","Number of tissue blocks and slides used",{"measure":30,"description":31,"timeFrame":12},"Pathologist time","Start of specimen review to end of specimen review",{"measure":33,"description":34,"timeFrame":12},"Technician time","Opening container to closing the block",{"measure":36,"description":37,"timeFrame":38},"Cost per case","Total amount billed","2 years post-WLE",null,{"allocation":41,"interventionModel":42,"interventionModelDescription":39,"primaryPurpose":43,"observationalModel":39,"timePerspective":39,"maskingInfo":44},"RANDOMIZED","PARALLEL","DIAGNOSTIC",{"masking":45,"maskingDescription":39,"whoMasked":39},"NONE",[47,53],{"label":48,"type":49,"description":50,"interventionNames":51},"Standard Breadloafing","ACTIVE_COMPARATOR","Control Arm",[52],"Diagnostic Test: Wide Local Excision",{"label":54,"type":55,"description":56,"interventionNames":57},"Comprehensive Peripheral and Deep Margin Assessment","EXPERIMENTAL","Experimental Arm",[52],[59],{"type":60,"name":61,"description":61,"armGroupLabels":62,"otherNames":39},"DIAGNOSTIC_TEST","Wide Local Excision",[54,48],[64],{"name":65,"affiliation":5,"role":66},"Joshua Mammen","PRINCIPAL_INVESTIGATOR",[68],{"name":69,"role":70,"phone":71,"phoneExt":39,"email":72},"IIT Office","CONTACT","402-559-4596","iitoffice@unmc.edu",[74],{"facility":75,"status":39,"city":76,"state":77,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"University of Nebraska Medical Center","Omaha","Nebraska","68198","United States","US",{"type":82,"coordinates":83},"Point",[84,85],-95.94043,41.25626,{"lat":85,"lon":84},[88,89],{"name":69,"role":70,"phone":71,"phoneExt":39,"email":72},{"name":65,"role":66,"phone":39,"phoneExt":39,"email":39},{"type":91,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100659747","trial-comparing-cpdma-versus-standard-breadloafing-in-wle-specimens-of-stage-1-ii-cutaneous-melanoma-100659747",false,"NCT07869381","Trial Comparing CPDMA Versus Standard Breadloafing in WLE Specimens of Stage 1-II Cutaneous Melanoma","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","Inclusion Criteria:\n\n* Age ≥19 years\n* Histologically confirmed clinical Stage I or II cutaneous melanoma, inclusive of acral melanoma\n* Candidate for guideline (NCCN) concordant wide local excision\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Prior wide local excision of the lesion\n* History of melanoma\n* Melanoma lesions at more than one site\n* Prior radiation therapy to the site\n* Pregnancy or lactation","ALL","19 Years",{"count":102,"type":103},282,"ESTIMATED","INTERVENTIONAL",[106],"NA","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:\n\n* 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?\n* Will more complete positive margin detection support more appropriate re-excision and lower local recurrence over two years?\n* Does CPDMA require greater pathology resource utilization and longer turnaround time than breadloafing?\n\nResearchers will compare standard breadloafing (control) arm to CPDMA (experimental) arm.\n\nParticipants will:\n\n* Undergo WLE.\n* Attend a follow-up visit at 4 months.",[109,110,111],"Cutaneous Melanoma, Stage II","Cutaneous Melanoma","Acral Melanoma",[110,113,114,61],"Breadloafing","CPDMA","NOT_YET_RECRUITING","2026-10-06",{"date":118,"type":119},"2026-10-09","ACTUAL",{"date":121,"type":103},"2026-12-24",{"date":123,"type":103},"2031-12-24",{"name":5,"class":6},1]