Study of Kidney Tumors in Younger Patients
Renal Tumors Classification, Biology, and Banking Study
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Clinical Trial Information
Trial Contact: Spinelli, Jennifer; Parker, Melanie; Armatti, Julie M; Doyle, Katherine M; Dubberly, Paige D
Trial Phone: 321.841.5357 ; 321-843-1036 ; 321-843-5284 ; 3218412008 ; 321-841-7561
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IRB No: AREN03B2
Protocol Abbrev: AREN03B2
Principal Investigator: Amy A. Smith, MD
Age Group: Pediatric
Secondary Protocol No: AREN03B2
Treatment: Other: laboratory biomarker analysis Other: cytology specimen collection procedure
Therapies Involved: Procedural
ClinicalTrials.gov ID: NCT00898365
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Objective
Collecting and storing samples of tumor tissue, blood, and urine from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
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Key Eligibility
Eligibility
Ages Eligible for Study: up to 29 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample
Study Population
Patients with the first occurrence of any tumor of the kidney identified on CT scan or MRI.
Criteria
Inclusion Criteria:
• 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
• Eligible tumors include (but are not limited to):
◦Nephroblastic tumors
◾Nephroblastoma (Wilms' tumor) (favorable histology, anaplasia [diffuse, focal])
◾Nephrogenic rests and nephroblastomatosis
◾Cystic nephroma and cystic partially differentiated nephroblastoma
◾Metanephric tumors (metanephric adenoma, metanephric adenofibroma, metanephric stromal tumor)
◦Mesoblastic nephroma (cellular, classic, mixed)
◦Clear cell sarcoma
◦Rhabdoid tumor (any malignant rhabdoid tumor occurring outside the central nervous system [CNS])
◦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)
◦Angiolipoma
◦Ossifying renal tumor of infancy
• Patients with the first occurrence of the following tumors are also eligible:
◦Extrarenal nephroblastoma or extrarenal neprogenic rests
◦Malignant rhabdoid tumor occurring anywhere outside the Central Nervous System
• Required specimens, reports, and copies of imaging studies must be available for submission or must become available during the required timeframe
• 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:
◦A complete set of recut hematoxylin and eosin (H & E) slides**
◦Representative formalin-fixed paraffin-embedded tissue block or if a block is unavailable, 10 unstained slides from a representative block of tumor**
◦Institutional pathology report, transmittal form and pathology checklist
◦Copies of images and institutional reports of CT and/or MRI abdomen and pelvis
◦Copies of images and institutional report of CT chest for all malignant tumors
◦Institutional surgical report(s)
◾Tissue must be from diagnosis, prior to any chemotherapy or radiation
• 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
• Patients with extrarenal Wilms tumor must have tumor tissue available for central review
• Patients with extra-CNS malignant rhabdoid tumor must have tumor tissue available for central review
• 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
