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

This phase II 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 start

Trial Details

NCT ID
NCT07621614
Phase
PHASE2
Sponsor
Children's Oncology Group
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Biospecimen Collection
  • Chest Radiography
  • Computed Tomography
  • Fludeoxyglucose F-18
  • Magnetic Resonance Imaging
  • Patient Observation
Locations (sample)
  • Oakland, California, United States|37.80437,-122.2708
  • Wilmington, Delaware, United States|39.74595,-75.54659
  • Jacksonville, Florida, United States|30.33218,-81.65565
  • Orlando, Florida, United States|28.53834,-81.37924
  • Pensacola, Florida, United States|30.42131,-87.21691

Key Eligibility Criteria

  • Patients ≤ 25 years old
  • Newly diagnosed localized cutaneous melanoma, atypical Spitz/Spitzoid tumors, or other atypical melanocytic neoplasm by local institution pathology…
  • Patients must have disease that is localized to the skin on clinical assessment. Note that staging imaging is not required for the determination of…
  • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients …

For full eligibility, visit ClinicalTrials.gov.

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