Clinical Trials (PDQ®)
|No phase specified||Biomarker/Laboratory analysis, Natural history/Epidemiology, Tissue collection/Repository||Active||Under 30||NCI, Other||AREN03B2|
NCI-2009-00416, CDR0000459797, COG-AREN03B2, U10CA098543, NCT00898365
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.
Further Study Information
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.
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.
- 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)
- 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
Trial Lead Organizations/Sponsors
Children's Oncology GroupNational Cancer Institute
|Elizabeth Mullen||Principal Investigator|
|Saint Peter's University Hospital|
|Stanley Calderwood||Ph: 732-745-8600ext6163|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00898365
ClinicalTrials.gov processed this data on November 12, 2014
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