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Study of Kidney Tumors in Young Patients

Conditions

Clear Cell Sarcoma of the Kidney | Congenital Mesoblastic Nephroma | Diffuse Hyperplastic Perilobar Nephroblastomatosis | Rhabdoid Tumor of the Kidney | Stage I Renal Cell Cancer | Stage I Wilms Tumor | Stage II Renal Cell Cancer | Stage II Wilms Tumor | Stage III Renal Cell Cancer | Stage III Wilms Tumor | Stage IV Renal Cell Cancer | Stage IV Wilms Tumor | Stage V Wilms Tumor

Trial Phase

N/A

Trial Purpose and Description

Trial Purpose

This laboratory study is looking at kidney tumors in young 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. It may also help the study of cancer in the future.


Trial Description

 

PRIMARY OBJECTIVES:

I. 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.

II. 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 OBJECTIVES:

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

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

III. Describe the sensitivity and specificity of abdominal computed tomography (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.

IV. 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.

V. 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 magnetic resonance imaging (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.


Participation Guidelines

Age:
Up to 29 Years
Gender:
Both

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])

- Patients with extra-renal nephroblastoma allowed

- 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 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

- Malignant rhabdoid tumor occurring anywhere outside the Central Nervous System

- 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 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)

- 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
Sponsor:
Children's Oncology Group
 
National Cancer Institute (NCI)
Dates:
February 2006
Last Updated:
August 5, 2014
Study HIC#:
0611002014

Clinicaltrials.gov ID: NCT00898365