| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
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Patients with the first occurrence of any tumor of the kidney identified on CT scan or MRI are eligible for this study; histologic diagnosis is not required prior to enrollment but is required for all patients once on study
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Eligible tumors include (but are not limited to):
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Nephroblastic tumors
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Nephroblastoma (Wilms' tumor) (favorable histology, anaplasia [diffuse, focal])
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Nephrogenic rests and nephroblastomatosis
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Cystic nephroma and cystic partially differentiated nephroblastoma
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Metanephric tumors (metanephric adenoma, metanephric adenofibroma, metanephric stromal tumor)
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Mesoblastic nephroma (cellular, classic, mixed)
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Clear cell sarcoma
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Rhabdoid tumor (any malignant rhabdoid tumor occurring outside the central nervous system [CNS])
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Renal epithelioid tumors of childhood (papillary renal cell carcinoma, medullary renal cell carcinoma, renal tumors associated with Xp11.2 translocations, oncocytic renal neoplasms after neuroblastoma)
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Angiolipoma
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Ossifying renal tumor of infancy
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Patients with the first occurrence of the following tumors are also eligible:
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Extrarenal nephroblastoma or extrarenal neprogenic rests
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Malignant rhabdoid tumor occurring anywhere outside the Central Nervous System
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Required specimens, reports, and copies of imaging studies must be available for submission or must become available during the required timeframe
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For ALL patients (with exception of bilateral, bilaterally predisposed or unilateral tumor in solitary kidney planning to enroll without biopsy), the following submissions are required:
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A complete set of recut hematoxylin and eosin (H & E) slides**
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Representative formalin-fixed paraffin-embedded tissue block or if a block is unavailable, 10 unstained slides from a representative block of tumor**
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Institutional pathology report, transmittal form and pathology checklist
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Copies of images and institutional reports of CT and/or MRI abdomen and pelvis
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Copies of images and institutional report of CT chest for all malignant tumors
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Institutional surgical report(s)
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Tissue must be from diagnosis, prior to any chemotherapy or radiation
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For patients with clinical features and required imaging findings consistent with the eligibility for the bilateral study, AREN0534 (or successor study), confirmed by central review, biopsy is not required; however, if biopsy is done, tissue must be submitted as for other renal tumors, and initial risk assignment will require pathology and surgical rapid central reviews; transmittal form and pathology checklist are also needed
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Patients with extrarenal Wilms tumor must have tumor tissue available for central review
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Patients with extra-CNS malignant rhabdoid tumor must have tumor tissue available for central review
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All patients and/or their parents or legal guardians must sign a written informed consent
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All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
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