A Study on How to Safely Guide Surgery for Melanoma and Similar Skin Tumors in Children Using Pathology and Genetic Information (NCT07621614)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
Age range: Not specified to 25 Years
🧪 Interventions in This Study
- Biospecimen Collection (PROCEDURE)
- Chest Radiography (PROCEDURE)
- Computed Tomography (PROCEDURE)
- Fludeoxyglucose F-18 (OTHER)
- Magnetic Resonance Imaging (PROCEDURE)
- Patient Observation (OTHER)
- Positron Emission Tomography (PROCEDURE)
- Re-Excision (PROCEDURE)
- Sentinel Lymph Node Biopsy (PROCEDURE)
- Ultrasound Imaging (PROCEDURE)
- Wide Local Excision (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (4 Sites)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
- Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania
- East Tennessee Childrens Hospital — Knoxville, Tennessee
- Saint Jude Children's Research Hospital — Memphis, Tennessee
📞 Contact the Study Coordinator
Phone: (267) 426-0948
Email: laetscht@chop.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Clinical Stage 0 Cutaneous Melanoma AJCC v8
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- Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With Cancer — Houston, Texas
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.