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

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

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Chest Radiography

Undergo chest x-ray

PROCEDURE

Computed Tomography

Undergo CT or FDG PET/CT

OTHER

Fludeoxyglucose F-18

Given FDG

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI, PET/MRI or brain MRI

OTHER

Patient Observation

Undergo observation

PROCEDURE

Positron Emission Tomography

Undergo whole body FDG PET/CT or PET/MRI

PROCEDURE

Re-Excision

Undergo narrow margin re-excision

PROCEDURE

Sentinel Lymph Node Biopsy

Undergo SLNB

PROCEDURE

Ultrasound Imaging

Undergo nodal basin ultrasound

PROCEDURE

Wide Local Excision

Undergo wide local excision

Sponsors & Collaborators

• Children's Oncology Group

  lead NETWORK

Principal Investigators

• Brittani K Seynnaeve · Children's Oncology Group

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

25 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-18

Primary Completion

2028-07-31

Completion

2028-07-31