| Inclusion Criteria: | 1) Patients must be < 30 years old at the time of diagnosis.
2) Patients who plan to enroll on a renal tumor therapeutic study must also meet the submission requirements for the relevant therapeutic study.
3) 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.
4) Patients with following tumors are eligible for this study: 1) Nephroblastoma (Wilms Tumor), favorable histology, anaplasia (Diffuse, Focal); 2) Nephrogenic rests and Nephroblastomatosis; 3) Cystic Nephroma and Cystic Partially Differentiated Nephroblastoma; 4) Metanephric Tumors (Metanephric Adenoma; Metanephric Adenofibroma; Metanephric Stromal Tumor);
5) #4 continued: 5) Mesoblastic Nephroma (Cellular, Classic, Mixed); 6) Clear Cell Sarcoma; 7) Rhabdoid tumor; 8) Renal Epithelioid Tumors of Childhood (Papillary renal cell carcinoma; Renal medullary carcinoma; Renal tumors associated with Xp11.2 translocations; Oncocytic renal neoplasms following neuroblastoma); 9) Angiolipoma; or, 10) Ossifying renal tumor of infancy.
6) Patients with an extrarenal nephroblastoma are also eligible.
7) Extrarenal tumors: Patients with the first occurrence of the following tumors are eligible: 1) Extrarenal nephroblastoma; 2) Malignant rhabdoid tumor occurring anywhere outside the Central Nervous System.
8) For patients with unilateral favorable histology Wilms tumor, tumor tissue from the biopsy and/or surgical procedure must be available for central review and diagnostic studies (LOH). This must be the first occurrence of Wilms tumor and patients must not have had any therapy prior to the biopsy and/or surgical procedure for their disease.
9) For patients with bilateral disease diagnosed by abdominal CT scan and confirmed by central review, biopsy is not required. However, if biopsy is done, tissue must be submitted as for other renal tumors.
10) For patients with Wilms tumor-predisposing syndromes and unilateral disease diagnosed by abdominal CT scan and confirmed by central review, biopsy is also not required. However, if biopsy is done, tissue must be submitted as for other renal tumors.
11) Patients with extra-renal Wilms tumor must have tumor tissue available for central review.
12) Patients with extra-CNS malignant rhabdoid tumor must have tumor tissue available for central review.
13) Required specimens and copies of imaging studies must be available for submission or must become available during the required timeframe.
14) Timing considerations: Patients must begin protocol therapy on renal tumor therapeutic studies by Day 14 after surgery or biopsy. It is suggested that pathology slides, operative notes, and radiology studies are submitted as soon as possible after nephrectomy/biopsy and by Day 7 to allow adequate time for central review to be completed. Samples may be submitted before an institutional diagnosis is rendered.
15) Patients may begin protocol therapy before central review is completed if medically indicated (e.g., significant symptoms from large tumor burden). However, enrollment on renal tumor therapeutic studies must occur within 7 days after beginning treatment or by Day 14 following surgery, whichever occurs first. If treatment begins before central review is completed, samples and studies must be submitted immediately to allow central review to occur.
16) Patients with renal tumors who are to be on the biology/banking study only must have their samples and studies submitted within 30 days of diagnostic surgery
17) All patients and/or their parents or legal guardians must sign a written informed consent.
18) All institutional, FDA, and NCI requirements for human studies must be met. |