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Clinical Stage 0 Cutaneous Melanoma AJCC v8Phase 2NCT07621614

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

A Phase 2 study testing Biospecimen Collection, Chest Radiography and Computed Tomography in people with Clinical Stage 0 Cutaneous Melanoma AJCC v8 and Clinical Stage I Cutaneous Melanoma AJCC v8, run by Children's Oncology Group at 13 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages Up to 25 years
What is being tested?
Biospecimen Collection, Chest Radiography and Computed Tomography
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
13 sitesUnited States
Study dates
15 May 2027to 31 Jul 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

13 sites in 1 country

United States13 sites, 13 recruiting

  • Dell Children's Medical Center of Central Texas

    Austin, Texas, 78723

    Site Public Contact, 512-628-1902, TXAUS-DL-SFCHemonc.research@ascension.org

    Shannon M. Cohn

    Recruiting

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

    Site Public Contact, 866-632-6789, askmdanderson@mdanderson.org

    Najat C. Daw

    Recruiting

  • Nemours Children's Clinic-Jacksonville

    Jacksonville, Florida, 32207

    Site Public Contact, 302-651-5572, Allison.bruce@nemours.org

    Sridhi Patel

    Recruiting

  • East Tennessee Childrens Hospital

    Knoxville, Tennessee, 37916

    Site Public Contact, 865-541-8266

    Susan E. Spiller

    Recruiting

  • Saint Jude Children's Research Hospital

    Memphis, Tennessee, 38105

    Site Public Contact, 888-226-4343, referralinfo@stjude.org

    Alberto S. Pappo

    Recruiting

  • Kaiser Permanente-Oakland

    Oakland, California, 94611

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Aarati V. Rao

    Recruiting

  • Nemours Children's Hospital

    Orlando, Florida, 32827

    Site Public Contact, 302-651-5572, Allison.bruce@nemours.org

    Sridhi Patel

    Recruiting

  • Nemours Children's Clinic - Pensacola

    Pensacola, Florida, 32504

    Site Public Contact, helpdesk@childrensoncologygroup.org

    Jeffrey H. Schwartz

    Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

    Site Public Contact, 267-425-5544, CancerTrials@email.chop.edu

    Theodore W. Laetsch

    Recruiting

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania, 15224

    Site Public Contact, 412-692-8570, jean.tersak@chp.edu

    Brittani K. Seynnaeve

    Recruiting

  • Primary Children's Hospital

    Salt Lake City, Utah, 84113

    Site Public Contact, 801-585-5270

    Casey J. Mehrhoff

    Recruiting

  • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

    Toledo, Ohio, 43606

    Site Public Contact, 419-824-1842, PCIOncResearch@promedica.org

    Jamie L. Dargart

    Recruiting

  • Alfred I duPont Hospital for Children

    Wilmington, Delaware, 19803

    Site Public Contact, 302-651-5572, Allison.bruce@nemours.org

    Sridhi Patel

    Recruiting

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To study the feasibility of central risk-based stratification of malignant and atypical cutaneous melanocytic tumors to guide primary surgical management.

SECONDARY OBJECTIVES:

  1. To evaluate the adherence rate to protocol-assigned surgical management in children with newly diagnosed melanoma, atypical Spitz/Spitzoid tumors, and other atypical melanocytic neoplasms.

II. To evaluate the surgery-related adverse events profile for patients treated with narrow re-excision without sentinel lymph node biopsy versus wide local excision +/- sentinel lymph node biopsy per standard adult cutaneous melanoma guidelines.

III. To describe progression free survival (PFS) and overall survival (OS) in pediatric patients with melanoma, atypical Spitz/Spitzoid tumors, and other atypical melanocytic neoplasms.

EXPLORATORY OBJECTIVES:

  1. To describe surgical reconstruction techniques for pediatric patients with atypical and malignant melanocytic tumors.

II. To describe the use of sentinel lymph node biopsy and rate of completion nodal dissection vs observation following positive sentinel lymph node including number of sentinel nodes sampled, size of largest metastatic nodal deposit, location of draining lymph node basin(s), number of lymph nodes resected at completion dissection.

III. To describe surgical complications of completion nodal dissection (from time of surgery to 90 days following surgery): wound dehiscence, seroma/hematoma, hemorrhage, infection, skin graft failure, necrosis of flap used for reconstruction, lymphocele, lymphedema, deep vein thrombosis.

IV. To evaluate the concordance between local treating center pathologic diagnosis and central pathology review diagnosis.

  1. To analyze the molecular characterization of melanocytic tumors to identify molecular and immunohistochemical biomarkers correlating with known clinical prognostic factors and outcome.

VI. To determine the number of Children's Oncology Group (COG) institutions that open the study within 18 months of activation.

OUTLINE: Patients with not atypical pathology are assigned to the Observation Arm. Patients with atypical low-risk tumors are assigned to Treatment Arm A and patients with atypical high-risk tumors are assigned to Treatment Arm B.

OBSERVATION ARM: Patients undergo observation throughout the study.

TREATMENT ARM A: Patients may undergo narrow margin re-excision without sentinel lymph node biopsy.

After completion of study intervention, patients are followed every 6 months for 1 year then every year for up to 5 years.

TREATMENT ARM B: Patients undergo wide local excision with or without sentinel lymph node biopsy (SLNB) per standard guidelines. Patients may also undergo blood sample collection, chest x-ray, computed tomography (CT), magnetic resonance imaging (MRI), whole-body fludeoxyglucose F-18 (FDG) positron emission tomography (PET)/CT or PET/MRI, nodal basin ultrasound, and brain MRI on study.

After completion of study treatment, patients are followed every 3-6 months for years 1 and 2, every 6 months up to year 5.

Being tested
Biospecimen Collection, Chest Radiography, Computed Tomography, Fludeoxyglucose F-18, Magnetic Resonance Imaging
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo blood sample collection

  • Chest RadiographyProcedure or surgery

    Also called Chest X-ray

    Undergo chest x-ray

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT or FDG PET/CT

  • Fludeoxyglucose F-18Other

    Also called 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18

    Given FDG

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI, PET/MRI or brain MRI

  • Patient ObservationOther

    Also called Active Surveillance, deferred therapy, expectant management, Observation

    Undergo observation

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo whole body FDG PET/CT or PET/MRI

  • Re-ExcisionProcedure or surgery

    Also called Reexcision

    Undergo narrow margin re-excision

  • Sentinel Lymph Node BiopsyProcedure or surgery

    Also called Sentinel Node Biopsy, Sentinel node biopsy alone, SLNB, SNB

    Undergo SLNB

  • Ultrasound ImagingProcedure or surgery

    Also called 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasonography

    Undergo nodal basin ultrasound

  • Wide Local ExcisionProcedure or surgery

    Also called Wide Resection

    Undergo wide local excision

Study groups in NCT07621614
Study groupRoleWhat they receive
Observation Arm (observation)Active comparatorPatients undergo observation throughout the study.
Receives: Other: Patient Observation
Treatment Arm A (narrow margin)ExperimentalPatients may undergo narrow margin re-excision without sentinel lymph node biopsy.
Receives: Procedure: Re-Excision
Treatment Arm B (wide local excision, SLNB)ExperimentalPatients 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.
Receives: Procedure: Biospecimen Collection; Procedure: Chest Radiography; Procedure: Computed Tomography; Other: Fludeoxyglucose F-18; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Procedure: Sentinel Lymph Node Biopsy; Procedure: Ultrasound Imaging; Procedure: Wide Local Excision

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility success rate

    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.

    Measured: Within 8 weeks of enrollment

Secondary outcomes (4)

  1. Adherence to surgical treatment arm assignment

    Will be defined as the proportion of patients who receive the specific protocol-assigned surgical management.

    Measured: Up to 5 years

  2. Incidence of grade 3-5 surgical adverse events

    Will be defined according to the Clavien-Dindo Classification. Will be summarized descriptively by study arm.

    Measured: From the time of surgery up to 90 days postoperatively

  3. Progression-free survival (PFS)

    PFS is defined as time from date of enrollment to the earliest occurrence of relapse, disease progression/recurrence, SMN, or death due to any cause. The 2-year PFS along with the confidence intervals will be estimated using the Kaplan-Meier survival curves for each study arm separately: observation arm, low-risk arm A, and high-risk arm B.

    Measured: Up to 2 years from enrollment

  4. Overall survival (OS)

    OS is the time from date of enrollment to date of death due to any reason. The 2-year OS along with the confidence intervals will be estimated using the Kaplan-Meier survival curves for each study arm separately: observation arm, low-risk arm A, and high-risk arm B.

    Measured: Up to 2 years from enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2026
  2. Study start15 May 2027 (estimated)
  3. Primary completion31 Jul 2028 (estimated)
  4. Study completion31 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
51 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07621614
Sponsor's protocol ID
ARAR2421
Other IDs
NCI-2026-03776, ARAR2421, ARAR2421, U10CA180886
Status last verified
Sep 2026
First submitted
27 May 2026
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, Chest Radiography and Computed Tomography in people with Clinical Stage 0 Cutaneous Melanoma AJCC v8 and Clinical Stage I Cutaneous Melanoma AJCC v8, run by Children's Oncology Group at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility success rate (time frame: Within 8 weeks of enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07621614.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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