Study of Kidney Tumors in Younger Patients

Introduction

• Org Study ID: AREN03B2
• NTC ID: NCT00898365
• Lead Sponsor Name: Children's Oncology Group
• Status: Recruiting

Conditions

• Kidney Oncocytoma
• Ossifying Renal Tumor of Infancy
• Papillary Renal Cell Carcinoma
• Renal Medullary Carcinoma
• Rhabdoid Tumor
• Translocation/TFE Renal Cell Carcinoma
• Wilms Tumor

Brief Summary

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.

Eligibility 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, 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 nephrectomy)

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

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