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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 sierpnia 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

51

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • California
      • Oakland, California, Stany Zjednoczone, 94611
        • Rekrutacyjny
        • Kaiser Permanente-Oakland
        • Kontakt:
          • Site Public Contact
          • Numer telefonu: 877-642-4691
          • E-mail: Kpoct@kp.org
        • Główny śledczy:
          • Aarati V. Rao
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
        • Rekrutacyjny
        • Children's Hospital of Philadelphia
        • Kontakt:
        • Główny śledczy:
          • Theodore W. Laetsch
      • Pittsburgh, Pennsylvania, Stany Zjednoczone, 15224
        • Rekrutacyjny
        • Children's Hospital of Pittsburgh of UPMC
        • Kontakt:
        • Główny śledczy:
          • Brittani K. Seynnaeve
    • Tennessee
      • Knoxville, Tennessee, Stany Zjednoczone, 37916
        • Rekrutacyjny
        • East Tennessee Childrens Hospital
        • Kontakt:
          • Site Public Contact
          • Numer telefonu: 865-541-8266
        • Główny śledczy:
          • Susan E. Spiller
      • Memphis, Tennessee, Stany Zjednoczone, 38105
        • Rekrutacyjny
        • Saint Jude Children's Research Hospital
        • Kontakt:
        • Główny śledczy:
          • Alberto S. Pappo

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Observation Arm (observation)
Patients undergo observation throughout the study.
Inny: Obserwacja pacjenta
Poddaj się obserwacji
Inne nazwy:
  • Obserwacja
  • Aktywny nadzór
  • odroczona terapia
  • oczekujące zarządzanie
  • Czujne czekanie
Eksperymentalny: Treatment Arm A (narrow margin)
Patients may undergo narrow margin re-excision without sentinel lymph node biopsy.
Procedura: Re-Excision
Undergo narrow margin re-excision
Inne nazwy:
  • Reexcision
Eksperymentalny: 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.
Procedura: Kolekcja próbek biologicznych
Poddaj się pobraniu próbki krwi
Inne nazwy:
  • Pobieranie próbek biologicznych
  • Zebrano próbki biologiczne
  • Kolekcja próbek
Inny: Fludeoksyglukoza F-18
Podany FDG
Inne nazwy:
  • 18FDG
  • FDG
  • fludeoksyglukoza F 18
  • Fludeoksyglukoza (18F)
  • Fludeoksyglukoza F18
  • Fluor-18 2-Fluoro-2-deoksy-D-glukoza
  • Fluorodeoksyglukoza F18
Procedura: Radiografia klatki piersiowej
Poddaj się prześwietleniu klatki piersiowej
Inne nazwy:
  • Rentgen klatki piersiowej
Procedura: Biopsja węzła wartowniczego
Poddaj się SLNB
Inne nazwy:
  • Biopsja węzła wartowniczego
  • Sama biopsja węzła wartowniczego
  • SLNB
  • SNB
Procedura: Tomografia komputerowa
Poddaj się CT lub FDG PET/CT
Inne nazwy:
  • Tomografia komputerowa
  • KOT
  • Skanowanie CAT
  • Tomografia komputerowa osiowa
  • Komputerowa tomografia osiowa
  • tomografia
  • Komputerowa tomografia osiowa (zabieg)
  • Tomografia komputerowa (CT).
  • Diagnostyczny skan CAT
  • Diagnostyczny typ usługi skanowania CAT
Procedura: Magnetic Resonance Imaging
Undergo MRI, PET/MRI or brain MRI
Inne nazwy:
  • MRI
  • Rezonans magnetyczny
  • Skanowanie rezonansu magnetycznego
  • Obrazowanie medyczne, rezonans magnetyczny / jądrowy rezonans magnetyczny
  • PAN
  • Obrazowanie MR
  • Obrazowanie NMR
  • NMRI
  • Obrazowanie magnetycznego rezonansu jądrowego
  • Obrazowanie metodą rezonansu magnetycznego (MRI)
  • sMRI
  • Rezonans magnetyczny (zabieg)
  • Strukturalny MRI
Procedura: Positron Emission Tomography
Undergo whole body FDG PET/CT or PET/MRI
Inne nazwy:
  • Obrazowanie medyczne, pozytonowa tomografia emisyjna
  • ZWIERZAK DOMOWY
  • Skanowanie zwierzęcia
  • Skan pozytonowej tomografii emisyjnej
  • Pozytonowa emisyjna tomografia komputerowa
  • PT
  • Pozytronowa tomografia emisyjna (zabieg)
Procedura: Ultrasound Imaging
Undergo nodal basin ultrasound
Inne nazwy:
  • Ultradźwięk
  • Dwuwymiarowe obrazowanie ultrasonograficzne w skali szarości
  • Dwuwymiarowe obrazowanie ultrasonograficzne
  • 2D-USA
  • Badanie ultrasonograficzne
  • USG, medyczne
  • NAS
  • Ultrasonografia
Procedura: Wide Local Excision
Undergo wide local excision
Inne nazwy:
  • Wide Resection

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Feasibility success rate
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Adherence to surgical treatment arm assignment
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Surgical reconstruction techniques for pediatric patients with atypical and malignant melanocytic tumors
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Within 18 months of protocol activation
The total number will be reported.
Within 18 months of protocol activation

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Children's Oncology Group

Śledczy

  • Główny śledczy: Brittani K Seynnaeve, Children's Oncology Group

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

15 maja 2027

Zakończenie podstawowe (Szacowany)

31 lipca 2028

Ukończenie studiów (Szacowany)

31 lipca 2028

Daty rejestracji na studia

Pierwszy przesłany

27 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

27 maja 2026

Pierwszy wysłany (Rzeczywisty)

2 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

2 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

31 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • ARAR2421 (Inny identyfikator: CTEP)
  • U10CA180886 (Grant/umowa NIH USA)
  • NCI-2026-03776 (Identyfikator rejestru: CTRP (Clinical Trial Reporting Program))

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Tak

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