A Study on How to Safely Guide Surgery for Melanoma and Similar Skin Tumors in Children Using Pathology and Genetic Information

NCT07621614 | Not Yet Recruiting

• 3 other identifiers: ARAR2421NCI-2026-03776U10CA180886
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

Brief Summary

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/Spitzoid 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/or recurrence (coming back after a period of improvement), and atypical and high risk for spread and/or 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/Spitzoid tumors or other atypical melanocytic tumors.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Feasibility success rate

  Will be defined as the proportion of patients for whom risk stratification can be returned to the treating institution based on pathology and molecular data obtained through rapid central review.

  Within 8 weeks of enrollment

Secondary Outcomes (4)

• Adherence to surgical treatment arm assignment

  Up to 5 years

• Incidence of grade 3-5 surgical adverse events

  From the time of surgery up to 90 days postoperatively

• Progression-free survival (PFS)

  From the date of enrollment to the earliest occurrence of relapse, disease progression/recurrence, secondary malignant neoplasm, or death due to any cause, assessed up to 5 years

• Overall survival (OS)

  From the date of enrollment to date of death due to any reason, assessed up to 5 years

Other Outcomes (6)

• Surgical reconstruction techniques for pediatric patients with atypical and malignant melanocytic tumors

  Up to 5 years

• The proportion of patients who undergo sentinel lymph node biopsy (SLNB) among the eligible high-risk arm B patients

  Up to 5 years

• Surgical complications of completion nodal dissection

  From the time of surgery to 90 days following surgery

Study Arms (3)

Observation Arm (observation)

ACTIVE COMPARATOR

Patients undergo observation throughout the study.

Other: Patient Observation

Treatment Arm A (narrow margin)

EXPERIMENTAL

Patients may undergo narrow margin re-excision without sentinel lymph node biopsy.

Procedure: Re-Excision

Treatment Arm B (wide local excision, SLNB)

EXPERIMENTAL

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/CT or PET/MRI, nodal basin ultrasound, and brain MRI on study.

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

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

Treatment Arm B (wide local excision, SLNB)

Chest Radiography PROCEDURE

Undergo chest x-ray

Also known as: Chest X-ray

Treatment Arm B (wide local excision, SLNB)

Computed Tomography PROCEDURE

Undergo CT or FDG PET/CT

Also known as: 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

Treatment Arm B (wide local excision, SLNB)

Fludeoxyglucose F-18 OTHER

Given FDG

Also known as: 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18

Treatment Arm B (wide local excision, SLNB)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI, PET/MRI or brain MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Treatment Arm B (wide local excision, SLNB)

Patient Observation OTHER

Undergo observation

Also known as: Active Surveillance, deferred therapy, expectant management, Observation, Watchful Waiting

Observation Arm (observation)

Positron Emission Tomography PROCEDURE

Undergo whole body FDG PET/CT or PET/MRI

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Treatment Arm B (wide local excision, SLNB)

Re-Excision PROCEDURE

Undergo narrow margin re-excision

Also known as: Reexcision

Treatment Arm A (narrow margin)

Sentinel Lymph Node Biopsy PROCEDURE

Undergo SLNB

Also known as: Sentinel Node Biopsy, Sentinel node biopsy alone, SLNB, SNB

Treatment Arm B (wide local excision, SLNB)

Ultrasound Imaging PROCEDURE

Undergo nodal basin ultrasound

Also known as: 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasonography, Ultrasound, Ultrasound Test, Ultrasound, Medical, US

Treatment Arm B (wide local excision, SLNB)

Wide Local Excision PROCEDURE

Undergo wide local excision

Also known as: Wide Resection

Treatment Arm B (wide local excision, SLNB)

Eligibility Criteria

• Age: Up to 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients ≤ 25 years old
• Newly diagnosed localized cutaneous melanoma, atypical Spitz/Spitzoid tumors, or other atypical melanocytic neoplasm by local institution pathology report
• 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
• 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
• Patients must not have received any prior chemotherapy, immunotherapy, targeted therapy, radiation, or surgical therapy for melanoma other than the permitted biopsy/excision of the lesion for which they are enrolling. Note that prior biopsies/surgery for other benign melanocytic lesions is permitted

You may not qualify if:

• Patients ≥ 18 years old with conventional adult-type melanoma are excluded. Note that patients 18-25 years old with atypical Spitz/Spitzoid tumors, or other atypical melanocytic neoplasms are eligible
• Patients with clinical evidence of metastatic disease such as palpable malignant adenopathy or symptomatic distant metastases are not eligible
• 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/excision, including re-biopsy, of the lesion
• Any of the following diagnoses
• Congenital nevi-associated proliferative nodules
• Agminated Spitz nevi/tumors
• Dysplastic nevus
• Combined nevus
• CRTC1::TRIM11 and/or MED15::ATF1 fused tumors (molecular testing is not required prior to enrollment)
• Pre-existing conditions:
• Solid organ transplant recipients
• 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
• All patients and/or their parents or legal guardians must sign a written informed consent
• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Sponsors & Collaborators

• Children's Oncology Group: lead

MeSH Terms

Conditions

Melanoma

Interventions

Specimen Handling; X-Rays; Fluorodeoxyglucose F18; Magnetic Resonance Spectroscopy; Watchful Waiting; Observation; Sentinel Lymph Node Biopsy; High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Deoxyglucose; Deoxy Sugars; Carbohydrates; Spectrum Analysis; Chemistry Techniques, Analytical; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Methods; Biopsy; Cytodiagnosis; Cytological Techniques; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Ultrasonic Waves; Sound; Radiation, Nonionizing

Study Officials

• Brittani K Seynnaeve

  Children's Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 2, 2026
• Study Start (Estimated): August 18, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: June 5, 2026

Record last verified: 2026-06