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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

maanantai 31. elokuuta 2026 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Rekrytointi

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

51

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Yhdysvallat
    • California
      • Oakland, California, Yhdysvallat, 94611
        • Rekrytointi
        • Kaiser Permanente-Oakland
        • Ottaa yhteyttä:
          • Site Public Contact
          • Puhelinnumero: 877-642-4691
          • Sähköposti: Kpoct@kp.org
        • Päätutkija:
          • Aarati V. Rao
    • Pennsylvania
      • Philadelphia, Pennsylvania, Yhdysvallat, 19104
        • Rekrytointi
        • Children's Hospital of Philadelphia
        • Ottaa yhteyttä:
        • Päätutkija:
          • Theodore W. Laetsch
      • Pittsburgh, Pennsylvania, Yhdysvallat, 15224
        • Rekrytointi
        • Children's Hospital of Pittsburgh of UPMC
        • Ottaa yhteyttä:
        • Päätutkija:
          • Brittani K. Seynnaeve
    • Tennessee
      • Knoxville, Tennessee, Yhdysvallat, 37916
        • Rekrytointi
        • East Tennessee Childrens Hospital
        • Ottaa yhteyttä:
          • Site Public Contact
          • Puhelinnumero: 865-541-8266
        • Päätutkija:
          • Susan E. Spiller
      • Memphis, Tennessee, Yhdysvallat, 38105
        • Rekrytointi
        • Saint Jude Children's Research Hospital
        • Ottaa yhteyttä:
        • Päätutkija:
          • Alberto S. Pappo

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Lapsi
  • Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Ei satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Active Comparator: Observation Arm (observation)
Patients undergo observation throughout the study.
Muut: Potilaan tarkkailu
Käy tarkkailussa
Muut nimet:
  • Havainto
  • Aktiivinen valvonta
  • lykätty terapia
  • odottava hallinta
  • Valpas Odotus
Kokeellinen: Treatment Arm A (narrow margin)
Patients may undergo narrow margin re-excision without sentinel lymph node biopsy.
Menettely: Re-Excision
Undergo narrow margin re-excision
Muut nimet:
  • Reexcision
Kokeellinen: 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.
Menettely: Bionäytekokoelma
Suorita verinäytteiden otto
Muut nimet:
  • Biologinen näytekokoelma
  • Bionäyte kerätty
  • Näytteiden kokoelma
  • Näytteenotto
Muut: Fludeoksiglukoosi F-18
Koska FDG
Muut nimet:
  • 18FDG
  • FDG
  • Fludeoksiglukoosi F18
  • Fludeoksiglukoosi (18F)
  • Fluori-18 2-fluori-2-deoksi-D-glukoosi
  • Fluorodeoksiglukoosi F18
Menettely: Rintakehän röntgenkuvaus
Käy rintakehän röntgenkuvauksessa
Muut nimet:
  • Rintakehän röntgenkuvaus
Menettely: Sentinel-imusolmukkeen biopsia
Käy läpi SLNB
Muut nimet:
  • Sentinel Node Biopsia
  • Sentinel solmubiopsia yksin
  • SLNB
  • SNB
Menettely: Tietokonetomografia
Tee CT tai FDG PET/CT
Muut nimet:
  • CT
  • KISSA
  • Kerroskuvaus
  • Aksiaalinen tietokonetomografia
  • Tietokoneistettu aksiaalinen tomografia
  • Tietokonetomografia
  • tomografia
  • Tietokoneistettu aksiaalinen tomografia (menettely)
  • Tietokonetomografia (CT).
  • Diagnostinen CAT -skannaus
  • Diagnostinen kissan skannauspalvelutyyppi
Menettely: Magnetic Resonance Imaging
Undergo MRI, PET/MRI or brain MRI
Muut nimet:
  • MRI
  • Magneettinen resonanssi
  • Magneettiresonanssikuvausskannaus
  • Lääketieteellinen kuvantaminen, magneettiresonanssi / ydinmagneettinen resonanssi
  • HERRA
  • MR-kuvaus
  • MRI-skannaus
  • NMR-kuvaus
  • NMRI
  • Ydinmagneettinen resonanssikuvaus
  • Magneettiresonanssikuvaus (MRI)
  • sMRI
  • Magneettiresonanssikuvaus (menettely)
  • MRI:t
  • Rakenne MRI
Menettely: Positron Emission Tomography
Undergo whole body FDG PET/CT or PET/MRI
Muut nimet:
  • Lääketieteellinen kuvantaminen, positroniemissiotomografia
  • LEMMIKKI
  • PET-skannaus
  • Positroniemissiotomografiaskannaus
  • Positroniemissiotomografia
  • PT
  • Positroniemissiotomografia (menettely)
Menettely: Ultrasound Imaging
Undergo nodal basin ultrasound
Muut nimet:
  • Ultraääni
  • 2-ulotteinen harmaasävyinen ultraäänikuvaus
  • 2-ulotteinen ultraäänikuvaus
  • 2D-USA
  • Ultraääni testi
  • Ultraääni, lääketiede
  • MEILLE
Menettely: Wide Local Excision
Undergo wide local excision
Muut nimet:
  • Wide Resection

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Feasibility success rate
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Adherence to surgical treatment arm assignment
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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

Muut tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Surgical reconstruction techniques for pediatric patients with atypical and malignant melanocytic tumors
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Within 18 months of protocol activation
The total number will be reported.
Within 18 months of protocol activation

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Children's Oncology Group

Tutkijat

  • Päätutkija: Brittani K Seynnaeve, Children's Oncology Group

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Arvioitu)

Lauantai 15. toukokuuta 2027

Ensisijainen valmistuminen (Arvioitu)

Maanantai 31. heinäkuuta 2028

Opintojen valmistuminen (Arvioitu)

Maanantai 31. heinäkuuta 2028

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Keskiviikko 27. toukokuuta 2026

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Keskiviikko 27. toukokuuta 2026

Ensimmäinen Lähetetty (Todellinen)

Tiistai 2. kesäkuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Keskiviikko 2. syyskuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Maanantai 31. elokuuta 2026

Viimeksi vahvistettu

Lauantai 1. elokuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • ARAR2421 (Muu tunniste: CTEP)
  • U10CA180886 (Yhdysvaltain NIH-apuraha/sopimus)
  • NCI-2026-03776 (Rekisterin tunniste: CTRP (Clinical Trial Reporting Program))

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Ei

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

Yhdysvalloissa valmistettu ja sieltä viety tuote

Joo

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