Who is eligible for clinical trial NCT07621614?

Participants must meet the protocol's inclusion criteria for Clinical Stage 0 Cutaneous Melanoma AJCC v8. The stated age range is Not specified to 25 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT07621614 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-26

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

🟢 Recruiting Observational / Diagnostic 🩺 Clinical Procedure Protocol Sponsor: Children's Oncology Group

🩺 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: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (15 items).

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 Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Patients ≤ 25 years old
Newly diagnosed localized cutaneous melanoma, atypical Spitz/Spitzoid tumors, or other atypical melanocytic neoplasm by local institution pathology report
Patients must have disease that is localized to the skin on clinical assessment. Note that staging imaging is not required for the determination of eligibility, but if obtained prior to enrollment, all imaging must be consistent with localized cutaneous disease
Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \> 16 years of age and Lansky for patients ≤ 16 years of age
Patients must not have received any prior chemotherapy, immunotherapy, targeted therapy, radiation, or surgical therapy for melanoma other than the permitted biopsy/excision of the lesion for which they are enrolling. Note that prior biopsies/surgery for other benign melanocytic lesions is permitted

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Patients ≥ 18 years old with conventional adult-type melanoma are excluded. Note that patients 18-25 years old with atypical Spitz/Spitzoid tumors, or other atypical melanocytic neoplasms are eligible
Patients with clinical evidence of metastatic disease such as palpable malignant adenopathy or symptomatic distant metastases are not eligible
Patients who have undergone re-excision to achieve a negative margin or sentinel lymph node biopsy for the melanocytic neoplasm under study are not eligible. Note that this does not exclude patients who have undergone the permitted diagnostic biopsy/excision, including re-biopsy, of the lesion
Any of the following diagnoses
Congenital nevi-associated proliferative nodules
Agminated Spitz nevi/tumors
Dysplastic nevus
Combined nevus
CRTC1::TRIM11 and/or MED15::ATF1 fused tumors (molecular testing is not required prior to enrollment)
Pre-existing conditions:
Solid organ transplant recipients

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 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.

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Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With Cancer — Houston, Texas

Explore by condition: All Clinical Stage 0 Cutaneous Melanoma AJCC v8 clinical trials

💡 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.

🏛️ View Official NIH Record ↗