[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637599":3},{"organization":4,"armGroups":7,"interventions":33,"overallOfficials":156,"centralContacts":160,"locations":160,"responsibleParty":161,"collaborators":160,"id":163,"slug":164,"hasResults":165,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":160,"eligibilityCriteria":169,"healthyVolunteers":165,"sex":170,"minAge":160,"maxAge":171,"enrollmentInfo":172,"targetDuration":160,"studyType":175,"phases":176,"briefSummary":178,"conditions":179,"keywords":160,"overallStatus":186,"whyStopped":160,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":160},{"fullName":5,"class":6},"Children's Oncology Group","NETWORK",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Observation Arm (observation)","ACTIVE_COMPARATOR","Patients undergo observation throughout the study.",[13],"Other: Patient Observation",{"label":15,"type":16,"description":17,"interventionNames":18},"Treatment Arm A (narrow margin)","EXPERIMENTAL","Patients may undergo narrow margin re-excision without sentinel lymph node biopsy.",[19],"Procedure: Re-Excision",{"label":21,"type":16,"description":22,"interventionNames":23},"Treatment Arm B (wide local excision, SLNB)","Patients undergo wide local excision with or without sentinel lymph node biopsy per standard guidelines. Patients may also undergo blood sample collection, chest x-ray, CT, MRI, whole-body FDG PET\u002FCT or PET\u002FMRI, nodal basin ultrasound, and brain MRI on study.",[24,25,26,27,28,29,30,31,32],"Procedure: Biospecimen Collection","Procedure: Chest Radiography","Procedure: Computed Tomography","Other: Fludeoxyglucose F-18","Procedure: Magnetic Resonance Imaging","Procedure: Positron Emission Tomography","Procedure: Sentinel Lymph Node Biopsy","Procedure: Ultrasound Imaging","Procedure: Wide Local Excision",[34,44,50,67,80,100,110,122,128,137,150],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"PROCEDURE","Biospecimen Collection","Undergo blood sample collection",[21],[40,41,42,43],"Biological Sample Collection","Biospecimen Collected","Sample Collection","Specimen Collection",{"type":35,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Chest Radiography","Undergo chest x-ray",[21],[49],"Chest X-ray",{"type":35,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"Computed Tomography","Undergo CT or FDG PET\u002FCT",[21],[55,56,57,58,59,60,61,62,63,64,65,66],"CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","Computerized Tomography (CT) scan","CT","CT Scan","Diagnostic CAT Scan","Diagnostic CAT Scan Service Type","tomography",{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":72},"OTHER","Fludeoxyglucose F-18","Given FDG",[21],[73,74,75,76,77,78,79],"18FDG","FDG","Fludeoxyglucose (18F)","fludeoxyglucose F 18","Fludeoxyglucose F18","Fluorine-18 2-Fluoro-2-deoxy-D-Glucose","Fluorodeoxyglucose F18",{"type":35,"name":81,"description":82,"armGroupLabels":83,"otherNames":84},"Magnetic Resonance Imaging","Undergo MRI, PET\u002FMRI or brain MRI",[21],[85,86,87,88,89,90,91,92,93,94,95,96,97,98,99],"Magnetic Resonance","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","MRIs","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging","sMRI","Structural MRI",{"type":68,"name":101,"description":102,"armGroupLabels":103,"otherNames":104},"Patient Observation","Undergo observation",[9],[105,106,107,108,109],"Active Surveillance","deferred therapy","expectant management","Observation","Watchful Waiting",{"type":35,"name":111,"description":112,"armGroupLabels":113,"otherNames":114},"Positron Emission Tomography","Undergo whole body FDG PET\u002FCT or PET\u002FMRI",[21],[115,116,117,118,119,120,121],"Medical Imaging, Positron Emission Tomography","PET","PET Scan","Positron emission tomography (procedure)","Positron Emission Tomography Scan","Positron-Emission Tomography","PT",{"type":35,"name":123,"description":124,"armGroupLabels":125,"otherNames":126},"Re-Excision","Undergo narrow margin re-excision",[15],[127],"Reexcision",{"type":35,"name":129,"description":130,"armGroupLabels":131,"otherNames":132},"Sentinel Lymph Node Biopsy","Undergo SLNB",[21],[133,134,135,136],"Sentinel Node Biopsy","Sentinel node biopsy alone","SLNB","SNB",{"type":35,"name":138,"description":139,"armGroupLabels":140,"otherNames":141},"Ultrasound Imaging","Undergo nodal basin ultrasound",[21],[142,143,144,145,146,147,148,149],"2-Dimensional Grayscale Ultrasound Imaging","2-Dimensional Ultrasound Imaging","2D-US","Ultrasonography","Ultrasound","Ultrasound Test","Ultrasound, Medical","US",{"type":35,"name":151,"description":152,"armGroupLabels":153,"otherNames":154},"Wide Local Excision","Undergo wide local excision",[21],[155],"Wide Resection",[157],{"name":158,"affiliation":5,"role":159},"Brittani K Seynnaeve","PRINCIPAL_INVESTIGATOR",null,{"type":162,"investigatorFullName":160,"investigatorTitle":160,"investigatorAffiliation":160,"oldNameTitle":160,"oldOrganization":160},"SPONSOR","100637599","a-study-on-how-to-safely-guide-surgery-for-melanoma-and-similar-skin-tumors-in-children-using-pathology-and-genetic-information-100637599",false,"NCT07621614","A Study on How to Safely Guide Surgery for Melanoma and Similar Skin Tumors in Children Using Pathology and Genetic Information","A Multi-Institutional Central Pathology and Molecular Risk-Based Stratification Study of Surgical Management for Melanoma, Atypical Spitz\u002FSpitzoid Tumors, and Other Atypical Melanocytic Neoplasms in Pediatric Patients","Inclusion Criteria:\n\n* Patients ≤ 25 years old\n* Newly diagnosed localized cutaneous melanoma, atypical Spitz\u002FSpitzoid tumors, or other atypical melanocytic neoplasm by local institution pathology report\n* Patients must have disease that is localized to the skin on clinical assessment. Note that staging imaging is not required for the determination of eligibility, but if obtained prior to enrollment, all imaging must be consistent with localized cutaneous disease\n* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \\> 16 years of age and Lansky for patients ≤ 16 years of age\n* Patients must not have received any prior chemotherapy, immunotherapy, targeted therapy, radiation, or surgical therapy for melanoma other than the permitted biopsy\u002Fexcision of the lesion for which they are enrolling. Note that prior biopsies\u002Fsurgery for other benign melanocytic lesions is permitted\n\nExclusion Criteria:\n\n* Patients ≥ 18 years old with conventional adult-type melanoma are excluded. Note that patients 18-25 years old with atypical Spitz\u002FSpitzoid tumors, or other atypical melanocytic neoplasms are eligible\n* Patients with clinical evidence of metastatic disease such as palpable malignant adenopathy or symptomatic distant metastases are not eligible\n* Patients who have undergone re-excision to achieve a negative margin or sentinel lymph node biopsy for the melanocytic neoplasm under study are not eligible. Note that this does not exclude patients who have undergone the permitted diagnostic biopsy\u002Fexcision, including re-biopsy, of the lesion\n* Any of the following diagnoses\n\n  * Congenital nevi-associated proliferative nodules\n  * Agminated Spitz nevi\u002Ftumors\n  * Dysplastic nevus\n  * Combined nevus\n  * CRTC1::TRIM11 and\u002For MED15::ATF1 fused tumors (molecular testing is not required prior to enrollment)\n* Pre-existing conditions:\n\n  * Solid organ transplant recipients\n  * Known melanoma predisposition syndrome (i.e., patients with previously known pathogenic variants in moderate and high penetrance melanoma susceptibility genes \\[i.e., CDKN2A, CDK4, BAP1, POT1, TERT promoter, ACD, TERF2IP\\] or Xeroderma Pigmentosum). Note germline testing is not required prior to enrollment\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met","ALL","25 Years",{"count":173,"type":174},51,"ESTIMATED","INTERVENTIONAL",[177],"NA","This clinical trial compares the effect of using risk-based stratification to guide surgical management to the usual approach in treating cutaneous melanoma, atypical Spitz\u002FSpitzoid tumors or other atypical melanocytic tumors that have not spread to other parts of the body (localized). Melanoma is a cancer that in children is sometimes difficult to tell apart from benign (not harmful) or atypical (uncertain if harmful) skin lesions. Failure to diagnose melanoma can result in inadequate surgical removal and increase the risk of recurrence and metastatic disease (spread from where it first started to other places in the body). In addition, diagnosing a tumor a benign (not cancer) tumor as cancer may lead to unnecessary surgery and treatment. This trial reviews tumor pathology and genetic markers and classifies the tumor as not atypical, atypical but low risk for spread and\u002For recurrence (coming back after a period of improvement), and atypical and high risk for spread and\u002For recurrence. The classifications are then used to provide surgical recommendations. Tumors that are not atypical do not receive any surgical treatment. Low-risk recommendations include removing a small layer of normal skin around the tumor. High-risk recommendations include the usual adult melanoma approach of removing a larger layer of normal skin around the tumor with or without a biopsy of the sentinel lymph node (the first lymph node to which tumor cells are likely to spread from a primary tumor). Risk-based guided surgical management may help avoid unnecessary surgery while improving outcomes in younger patients with localized cutaneous melanoma, atypical Spitz\u002FSpitzoid tumors or other atypical melanocytic tumors.",[180,181,182,183,184,185],"Clinical Stage 0 Cutaneous Melanoma AJCC v8","Clinical Stage I Cutaneous Melanoma AJCC v8","Clinical Stage II Cutaneous Melanoma AJCC v8","Cutaneous Melanocytic Neoplasm","Cutaneous Melanoma","Cutaneous Spitz Melanocytoma","NOT_YET_RECRUITING","2026-06-03",{"date":189,"type":190},"2026-06-05","ACTUAL",{"date":192,"type":174},"2026-08-18",{"date":194,"type":174},"2028-07-31",{"name":5,"class":6}]