Trial Information

Renal Tumors Classification, Biology, and Banking Study

OBJECTIVES:

Primary

- Classify patients with renal tumors by histological categorization,
surgico-pathological stage, presence of metastases, age at diagnosis, tumor weight, and
loss of heterozygosity for chromosomes 1p and 16q, to define eligibility for a series
of therapeutic studies.

- Maintain a biological samples bank to make specimens available to scientists to
evaluate additional potential biological prognostic variables and for the conduct of
other research by scientists.

Secondary

- Monitor outcome for those patients who are not eligible for a subsequent therapeutic
study.

- Describe whether the pulmonary tumor burden correlates with outcome in patients with
stage IV disease.

- Describe the sensitivity and specificity of abdominal CT scan by comparing it with
surgical and pathologic findings for identification of local tumor spread beyond the
renal capsule to adjacent muscle and organs, lymph node involvement at the renal hilum
and in the retroperitoneum, preoperative tumor rupture, and metastases to the liver.

- Compare the sensitivity and specificity of pre-operative abdominal CT scan and MRI for
the identification and differentiation of nephrogenic rests and Wilms' tumor in
children with multiple renal lesions.

- Correlate the method of conception (natural vs assisted reproductive technology) with
the development of Wilms' tumor.

OUTLINE: This is a multicenter study.

Tumor tissue, blood, and urine samples are collected for research studies, including
immunohistochemistry. CT scans and MRIs are also performed. Loss of heterozygosity analyses
(chromosome 1p and 16q) are performed by extraction of DNA. DNA polymorphisms are assayed by
polymerase chain reaction using standard methodology. Leftover specimens are archived for
future studies.

Patients are followed periodically for 5 years.

PROJECTED ACCRUAL: There are no sample size goals for this study.