Study of Kidney Tumors in Younger Patients


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Trial ID: NCT00898365


This research trial studies kidney tumors in younger patients. Collecting and storing samples of tumor tissue, blood, and urine from patients with cancer to study in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

Official Title

Renal Tumors Classification, Biology, and Banking Study


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,

         - 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, forms, and copies of imaging studies must be available or
   will become available for submission and the institution must intend on submitting
   them as described in the protocol procedures

   - For ALL patients, (with exception of bilateral, bilaterally predisposed, multicentric,
   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 (including from
      sampled lymph nodes, if patient had upfront nephrectomy)

         - * Tissue must be from diagnosis, prior to any renal tumor directed
         chemotherapy or radiation (only exception is for presumed favorable
         histology Wilms tumor [FHWT] patients discovered to have diffuse anaplastic
         Wilms tumor [DAWT] at delayed nephrectomy and plan to enroll at delayed

      - Representative formalin-fixed paraffin-embedded tissue block or if a block is
      unavailable, 10 unstained slides from a representative block of tumor, if

         - Tissue must be from diagnosis, prior to any renal tumor directed
         chemotherapy or radiation (only exception is for presumed FHWT patients
         discovered to have DAWT at delayed nephrectomy and plan to enroll at delayed

      - Institutional pathology report, Specimen Transmittal Form, and Pre-Treatment
      Pathology Checklist

      - Copies of images and institutional reports of CT and/or MRI abdomen and pelvis,
      and Pre Treatment Imaging Checklist

      - Copies of images and institutional report of chest CT for all malignant tumors

      - Institutional surgical report(s) and Pre-Treatment Surgical Checklist

      - CRFs: Staging Checklist and Metastatic Disease Form (if metastatic disease is
      noted on imaging)

         - Patients with bilateral, bilaterally predisposed, multicentric, or
         unilateral tumor in solitary kidney planning to enroll without biopsy via
         imaging only - these patients will not have central review or have a risk
         assignment issued, but may contribute to specimen banking for future
         research. 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. The Specimen Transmittal Form and Pre
         Treatment Pathology Checklist are also needed.

      - Please note: if the above required items are not received within 120 days of
      study enrollment, the patient will be considered off study

   - All patients and/or their parents or legal guardians must sign a written informed

   - All institutional, Food and Drug Administration (FDA), and National Cancer Institute
   (NCI) requirements for human studies must be met


other: laboratory biomarker analysis

other: cytology specimen collection procedure


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Christina Baggott

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