NCT07621614 · Children's Oncology Group
A Study on How to Safely Guide Surgery for Melanoma and Similar Skin Tumors in Children Using Pathology and Genetic Information
What this study is about
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).
View original scientific description
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.
Interventions
PROCEDURE
Biospecimen Collection
Undergo blood sample collection
PROCEDURE
Chest Radiography
Undergo chest x-ray
PROCEDURE
Computed Tomography
Undergo CT or FDG PET/CT
OTHER
Fludeoxyglucose F-18
Given FDG
PROCEDURE
Magnetic Resonance Imaging
Undergo MRI, PET/MRI or brain MRI
OTHER
Patient Observation
Undergo observation
PROCEDURE
Positron Emission Tomography
Undergo whole body FDG PET/CT or PET/MRI
PROCEDURE
Re-Excision
Undergo narrow margin re-excision
PROCEDURE
Sentinel Lymph Node Biopsy
Undergo SLNB
PROCEDURE
Ultrasound Imaging
Undergo nodal basin ultrasound
PROCEDURE
Wide Local Excision
Undergo wide local excision
Primary outcome measures
Feasibility success rate
Time frame: Within 8 weeks of enrollment
Will be defined as the proportion of patients for whom risk stratification can be returned to the treating institution based on pathology and molecular data obtained through rapid central review.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
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
- Known melanoma predisposition syndrome (i.e., patients with previously known pathogenic variants in moderate and high penetrance melanoma susceptibility genes \[i.e., CDKN2A, CDK4, BAP1, POT1, TERT promoter, ACD, TERF2IP\] or Xeroderma Pigmentosum). Note germline testing is not required prior to enrollment
- All patients and/or their parents or legal guardians must sign a written informed consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Where
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
- Knoxville, Tennessee
- Memphis, Tennessee
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 28, 2026 · Source of record for eligibility and locations