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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Phase changed: not applicable → Phase 2 Lead sponsor: Children's Oncology Group to Children's Oncology Group · Trial sites expanded: 5 → 13 locations · Eligibility criteria expanded, about 19 words · 1 more Show 4 more changesShow less
    • Lead sponsor: Children's Oncology Group to Children's Oncology Group
    • Trial sites expanded: 5 → 13 locations
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 3 of 4 entries
  2. Notable Start date: Aug 18, 2026 to May 15, 2027 Study sites: 4 to 5v4 Show 1 more changeShow less
    • Study sites: 4 to 5
  3. Notable Recruitment opened Trial sites expanded: 0 → 4 locationsv3 Show 1 more changeShow less
    • Trial sites expanded: 0 → 4 locations
  4. Minor Secondary endpoints: details revised at 1 of 4 entriesv2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 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.
Trial Details
NCT Number NCT07621614
Lead Sponsor Children's Oncology Group
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, Cutaneous Spitz Melanoma
Enrollment 51 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov