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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 51
- 试验地点
- 5
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Magnetic Resonance Imaging (Procedure)
Observation Arm (observation)
Patients undergo observation throughout the study.
干预措施: Patient Observation (Other)
Treatment Arm A (narrow margin)
Patients may undergo narrow margin re-excision without sentinel lymph node biopsy.
干预措施: Re-Excision (Procedure)
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.
干预措施: Computed Tomography (Procedure)
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.
干预措施: Positron Emission Tomography (Procedure)
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.
干预措施: Sentinel Lymph Node Biopsy (Procedure)
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.
干预措施: Ultrasound Imaging (Procedure)
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.
干预措施: Wide Local Excision (Procedure)
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.
干预措施: Biospecimen Collection (Procedure)
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.
干预措施: Chest Radiography (Procedure)
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.
干预措施: Fludeoxyglucose F-18 (Other)