Recruiting

Risk-Based Stratification

Sponsor:

Children's Oncology Group

Code:

NCT07621614

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

Eligibility Criteria

Sex: All

Age: 0 - 25

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Chest Radiography

Computed Tomography

Fludeoxyglucose F-18

Magnetic Resonance Imaging

Study Details

Brief summary:

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.

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

Study ID

NCT07621614

Start date

May 15, 2027

Status verified date

Aug, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 25

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

51 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Observation Arm (observation)

Patients undergo observation throughout the study.

experimental: Treatment Arm A (narrow margin)

Patients may undergo narrow margin re-excision without sentinel lymph node biopsy.

experimental: Treatment Arm B (wide local excision, SLNB)

Patients undergo wide local excision with or without sentinel lymph node biopsy per standard guidelines. Patients may also undergo blood sample collection, chest x-ray, CT, MRI, whole-body FDG PET/CT or PET/MRI, nodal basin ultrasound, and brain MRI on study.

Interventions

Biospecimen Collection

Undergo blood sample collection

Chest Radiography

Undergo chest x-ray

Computed Tomography

Undergo CT or FDG PET/CT

Fludeoxyglucose F-18

Given FDG

Magnetic Resonance Imaging

Undergo MRI, PET/MRI or brain MRI

Patient Observation

Undergo observation

Positron Emission Tomography

Undergo whole body FDG PET/CT or PET/MRI

Re-Excision

Undergo narrow margin re-excision

Sentinel Lymph Node Biopsy

Undergo SLNB

Ultrasound Imaging

Undergo nodal basin ultrasound

Wide Local Excision

Undergo wide local excision

Primary outcome measure

  • Feasibility success rate [ Time Frame: Within 8 weeks of enrollment ]

Central Contacts and Locations

Locations

Kaiser Permanente-Oakland

Recruiting

Oakland, California, United States, 94611

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Aarati V. Rao

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Site Public Contact

267-425-5544CancerTrials@email.chop.edu

Principal Investigator:

Theodore W. Laetsch

Children's Hospital of Pittsburgh of UPMC

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Site Public Contact

412-692-8570jean.tersak@chp.edu

Principal Investigator:

Brittani K. Seynnaeve

East Tennessee Childrens Hospital

Recruiting

Knoxville, Tennessee, United States, 37916

Contacts

Site Public Contact

865-541-8266

Principal Investigator:

Susan E. Spiller

Saint Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Site Public Contact

888-226-4343referralinfo@stjude.org

Principal Investigator:

Alberto S. Pappo

More Information

Sponsor

Children's Oncology Group

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Oncology Group on 2026-09-02.