RecruitingNot ApplicableNCT07621614

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/Spitzoid Tumors, and Other Atypical Melanocytic Neoplasms in Pediatric Patients


Sponsor

Children's Oncology Group

Enrollment

51 participants

Start Date

May 15, 2027

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Max Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Biospecimen Collection, a procedure called Chest Radiography, and others for people with clinical stage 0 cutaneous melanoma ajcc v8, clinical stage i cutaneous melanoma ajcc v8, and other related conditions. The study is currently recruiting participants at 4 locations. People eligible for this study include up to age 25 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREChest Radiography

Undergo chest x-ray

PROCEDUREComputed Tomography

Undergo CT or FDG PET/CT

OTHERFludeoxyglucose F-18

Given FDG

PROCEDUREMagnetic Resonance Imaging

Undergo MRI, PET/MRI or brain MRI

OTHERPatient Observation

Undergo observation

PROCEDUREPositron Emission Tomography

Undergo whole body FDG PET/CT or PET/MRI

PROCEDURERe-Excision

Undergo narrow margin re-excision

PROCEDURESentinel Lymph Node Biopsy

Undergo SLNB

PROCEDUREUltrasound Imaging

Undergo nodal basin ultrasound

PROCEDUREWide Local Excision

Undergo wide local excision


Locations(5)

Kaiser Permanente-Oakland

Oakland, California, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

East Tennessee Childrens Hospital

Knoxville, Tennessee, United States

Saint Jude Children's Research Hospital

Memphis, Tennessee, United States

View Full Details on ClinicalTrials.gov

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NCT07621614


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