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

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

Eligibility Criteria

Sex

ALL

Age

N/A - 25 Years

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Chest Radiography — PROCEDURE
  Undergo chest x-ray
• Computed Tomography — PROCEDURE
  Undergo CT or FDG PET/CT
• Fludeoxyglucose F-18 — OTHER
  Given FDG
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI, PET/MRI or brain MRI
• Patient Observation — OTHER
  Undergo observation
• Positron Emission Tomography — PROCEDURE
  Undergo whole body FDG PET/CT or PET/MRI
• Re-Excision — PROCEDURE
  Undergo narrow margin re-excision
• Sentinel Lymph Node Biopsy — PROCEDURE
  Undergo SLNB
• Ultrasound Imaging — PROCEDURE
  Undergo nodal basin ultrasound
• Wide Local Excision — PROCEDURE
  Undergo wide local excision

Study Details

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.

Key Dates

First listed

Jun 2, 2026

Start date

Aug 18, 2026

Status verified

Jun 2026

Primary completion

Jul 31, 2028

Completion

Jul 31, 2028

Study Design

Enrollment

51 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Observation Arm (observation)
  Patients undergo observation throughout the study.
• Experimental: Treatment Arm A (narrow margin)
  Patients may undergo narrow margin re-excision without sentinel lymph node biopsy.
• Experimental: 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/CT or PET/MRI, nodal basin ultrasound, and brain MRI on study.

Primary Outcome Measure

Feasibility success rate [ Time Frame: Within 8 weeks of enrollment ]

Locations (4)

Find similar trials in Philadelphia, PA

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