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

31 de agosto de 2026 actualizado por: Children's Oncology Group

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 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

PRIMARY OBJECTIVE:

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

SECONDARY OBJECTIVES:

I. 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:

I. 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.

V. 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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

51

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • California
      • Oakland, California, Estados Unidos, 94611
        • Reclutamiento
        • Kaiser Permanente-Oakland
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 877-642-4691
          • Correo electrónico: Kpoct@kp.org
        • Investigador principal:
          • Aarati V. Rao
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • Reclutamiento
        • Children's Hospital of Philadelphia
        • Contacto:
        • Investigador principal:
          • Theodore W. Laetsch
      • Pittsburgh, Pennsylvania, Estados Unidos, 15224
        • Reclutamiento
        • Children's Hospital of Pittsburgh of UPMC
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 412-692-8570
          • Correo electrónico: jean.tersak@chp.edu
        • Investigador principal:
          • Brittani K. Seynnaeve
    • Tennessee
      • Knoxville, Tennessee, Estados Unidos, 37916
        • Reclutamiento
        • East Tennessee Childrens Hospital
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 865-541-8266
        • Investigador principal:
          • Susan E. Spiller
      • Memphis, Tennessee, Estados Unidos, 38105
        • Reclutamiento
        • Saint Jude Children's Research Hospital
        • Contacto:
        • Investigador principal:
          • Alberto S. Pappo

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Observation Arm (observation)
Patients undergo observation throughout the study.
Otro: Observación del paciente
Someterse a observación
Otros nombres:
  • Observación
  • Vigilancia activa
  • terapia diferida
  • la conducta expectante
  • Espera vigilante
Experimental: Treatment Arm A (narrow margin)
Patients may undergo narrow margin re-excision without sentinel lymph node biopsy.
Procedimiento: Re-Excision
Undergo narrow margin re-excision
Otros nombres:
  • Reexcision
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.
Procedimiento: Colección de muestras biológicas
Someterse a la recolección de muestras de sangre
Otros nombres:
  • Recolección de muestras biológicas
  • Muestra biológica recolectada
  • Coleccion de especimenes
  • Recolección de muestras
Otro: Fludesoxiglucosa F-18
Dada la FDG
Otros nombres:
  • 18FDG
  • FDG
  • fludesoxiglucosa F 18
  • Fludesoxiglucosa (18F)
  • Fludesoxiglucosa F18
  • Flúor-18 2-Fluoro-2-desoxi-D-Glucosa
  • Fluorodesoxiglucosa F18
Procedimiento: Radiografía de tórax
Someterse a una radiografía de tórax
Otros nombres:
  • Radiografía de pecho
Procedimiento: Biopsia de ganglio linfático centinela
Someterse a SLNB
Otros nombres:
  • Biopsia de ganglio centinela
  • Biopsia de ganglio centinela sola
  • SLNB
  • SNB
Procedimiento: Tomografía computarizada
Someterse a TC o FDG PET/CT
Otros nombres:
  • Connecticut
  • GATO
  • Análisis de gato
  • Tomografía Axial Computarizada
  • Tomografía axial computarizada
  • Tomografía computarizada
  • tomografía
  • Tomografía axial computarizada (procedimiento)
  • Tomografía computarizada (TC)
  • Escaneo de gato de diagnóstico
  • Tipo de servicio de escaneo de gato de diagnóstico
Procedimiento: Magnetic Resonance Imaging
Undergo MRI, PET/MRI or brain MRI
Otros nombres:
  • Resonancia magnética
  • Resonancia magnetica
  • Exploración de imágenes por resonancia magnética
  • Imágenes Médicas, Resonancia Magnética / Resonancia Magnética Nuclear
  • SRES
  • Imágenes de RM
  • Imágenes de RMN
  • RMN
  • Imágenes de resonancia magnética nuclear
  • Imágenes por resonancia magnética (IRM)
  • resonancia magnética nuclear
  • Imágenes por resonancia magnética (procedimiento)
  • Resonancias magnéticas
  • Resonancia magnética estructural
Procedimiento: Positron Emission Tomography
Undergo whole body FDG PET/CT or PET/MRI
Otros nombres:
  • Imágenes médicas, tomografía por emisión de positrones
  • MASCOTA
  • Escaneo de mascotas
  • Tomografía por emisión de positrones
  • Tomografía de emisión de positrones
  • PT
  • Tomografía por emisión de positrones (procedimiento)
Procedimiento: Ultrasound Imaging
Undergo nodal basin ultrasound
Otros nombres:
  • Ultrasonido
  • Imagen de ultrasonido bidimensional en escala de grises
  • Imágenes de ultrasonido bidimensionales
  • 2D-EE. UU.
  • Prueba de ultrasonido
  • Ultrasonido Médico
  • A NOSOTROS
  • Ultrasonografía
Procedimiento: Wide Local Excision
Undergo wide local excision
Otros nombres:
  • Wide Resection

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Feasibility success rate
Periodo de tiempo: 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.
Within 8 weeks of enrollment

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Adherence to surgical treatment arm assignment
Periodo de tiempo: Up to 5 years
Will be defined as the proportion of patients who receive the specific protocol-assigned surgical management.
Up to 5 years
Incidence of grade 3-5 surgical adverse events
Periodo de tiempo: From the time of surgery up to 90 days postoperatively
Will be defined according to the Clavien-Dindo Classification. Will be summarized descriptively by study arm. Special attention will be given to the following surgical complications: wound dehiscence, seroma/hematoma, hemorrhage, infection, skin graft failure, necrosis of flap used for reconstruction, lymphocele, lymphedema, and deep vein thrombosis.
From the time of surgery up to 90 days postoperatively
Overall survival (OS)
Periodo de tiempo: From the date of enrollment to date of death due to any reason, assessed up to 5 years
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.
From the date of enrollment to date of death due to any reason, assessed up to 5 years
Progression-free survival (PFS)
Periodo de tiempo: From the date of enrollment to the earliest occurrence of relapse, disease progression/recurrence, secondary malignant neoplasm, or death due to any cause, assessed up to 5 years
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.
From the date of enrollment to the earliest occurrence of relapse, disease progression/recurrence, secondary malignant neoplasm, or death due to any cause, assessed up to 5 years

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Surgical reconstruction techniques for pediatric patients with atypical and malignant melanocytic tumors
Periodo de tiempo: Up to 5 years
The analysis will consist of a descriptive summary of the surgical reconstruction techniques utilized in this cohort. Reconstruction techniques will be categorized as follows: primary closure; delayed primary closure; closure by secondary intention; autologous skin graft; skin graft, other material; local tissue flap; free flap with microvascular reconstruction; amputation; other. Frequencies and percentages will be reported for each technique.
Up to 5 years
The proportion of patients who undergo sentinel lymph node biopsy (SLNB) among the eligible high-risk arm B patients
Periodo de tiempo: Up to 5 years
The proportion will be summarized. Among patients with a positive SLNB, the rate of subsequent completion nodal dissection versus observation will be reported. The 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 will be summarized using appropriate descriptive statistics.
Up to 5 years
Surgical complications of completion nodal dissection
Periodo de tiempo: From the time of surgery to 90 days following surgery
The occurrence of surgical complications including wound dehiscence, seroma or hematoma, hemorrhage, infection, skin graft failure, necrosis of flap used for reconstruction, lymphocele, lymphedema, and deep vein thrombosis will be summarized descriptively. The incidence of each complication will be calculated, accompanied by 95% confidence intervals if there are sufficient patients.
From the time of surgery to 90 days following surgery
Concordance between local treating center pathologic diagnosis and central pathology review diagnosis
Periodo de tiempo: Up to 5 years
Will be assessed by comparing both the initial local treating center enrolling pathologic diagnosis (without incorporating molecular testing data) with the final central pathology review diagnosis, and final local diagnosis (with available molecular data incorporation) with the final central pathology review diagnosis. Concordance will be defined as agreement between the local and central reviewer on the assigned diagnostic category. Concordance rates will be reported as proportions with corresponding confidence intervals. For discordant cases, additional descriptive analysis may explore the nature and direction of the discrepancies.
Up to 5 years
Molecular characterization of melanocytic tumors to identify molecular and immunohistochemical biomarkers correlating with known clinical prognostic factors and outcome
Periodo de tiempo: Up to 5 years
Will be addressed through descriptive and exploratory analyses of molecular and immunohistochemical (IHC) data collected from tumor samples. The frequency and distribution of molecular alterations and IHC marker expression will be summarized. Associations between individual biomarkers and known clinical prognostic factors, such as tumor Breslow depth, ulceration, increased mitotic index, high grade cytological atypia, clinical tumor diameter (> 1cm versus [vs.] ≤ 1 cm), diagnosis age (> 10 years vs. ≤ 10 years), will be evaluated using appropriate statistical methods (e.g., chi-square or Fisher's exact test for categorical variables, Wilcoxon rank-sum test for continuous variables). If number of events permits, exploratory analyses will assess the relationship between biomarkers and PFS. Kaplan-Meier curves may be used to illustrate differences in survival by biomarker status, and log-rank tests will assess statistical significance.
Up to 5 years
The number of Children's Oncology Group institutions that open the study within 18 months of activation
Periodo de tiempo: Within 18 months of protocol activation
The total number will be reported.
Within 18 months of protocol activation

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Children's Oncology Group

Investigadores

  • Investigador principal: Brittani K Seynnaeve, Children's Oncology Group

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

15 de mayo de 2027

Finalización primaria (Estimado)

31 de julio de 2028

Finalización del estudio (Estimado)

31 de julio de 2028

Fechas de registro del estudio

Enviado por primera vez

27 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

27 de mayo de 2026

Publicado por primera vez (Actual)

2 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

31 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • ARAR2421 (Otro identificador: CTEP)
  • U10CA180886 (Subvención/contrato del NIH de EE. UU.)
  • NCI-2026-03776 (Identificador de registro: CTRP (Clinical Trial Reporting Program))

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

Sí

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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