Study of Kidney Tumors in Young Patients

This study is currently recruiting participants.
Verified November 2012 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00898365
First received: May 9, 2009
Last updated: November 22, 2012
Last verified: November 2012

May 9, 2009
November 22, 2012
February 2006
Not Provided
  • 10-year disease-free survival [ Designated as safety issue: No ]
  • 10-year overall survival [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00898365 on ClinicalTrials.gov Archive Site
Loss of heterozygosity [ Designated as safety issue: No ]
Same as current
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Study of Kidney Tumors in Young Patients
Renal Tumors Classification, Biology, and Banking Study

RATIONALE: 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 DNA and identify biomarkers related to cancer. It may also help the study of cancer in the future.

PURPOSE: This laboratory study is looking at kidney tumors in young patients.

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.

Observational
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  • Kidney Cancer
  • Nonneoplastic Condition
  • Genetic: loss of heterozygosity analysis
  • Genetic: polymerase chain reaction
  • Genetic: polymorphism analysis
  • Other: immunohistochemistry staining method
  • Procedure: computed tomography
  • Procedure: magnetic resonance imaging
Not Provided
Khanna G, Rosen N, Anderson JR, Ehrlich PF, Dome JS, Gow KW, Perlman E, Barnhart D, Karolczuk K, Grundy P. Evaluation of diagnostic performance of CT for detection of tumor thrombus in children with Wilms tumor: A report from the Children's Oncology Group. Pediatr Blood Cancer. 2011 Jun 14; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
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DISEASE CHARACTERISTICS:

  • Diagnosis of renal tumors, including any of the following:

    • 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
  • Newly diagnosed disease
  • Paraffin-embedded tumor samples requested and available
  • Blood samples available
  • Urine samples requested and available
  • Copies of imaging studies available

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • No prior therapy for cancer
Both
up to 29 Years
No
Not Provided
United States,   Australia,   Canada,   Israel,   New Zealand,   Puerto Rico,   Switzerland
 
NCT00898365
CDR0000459797, COG-AREN03B2
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Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: Paul E. Grundy, MD Stollery Children's Hospital at University of Alberta Hospital
Investigator: Jeffrey S. Dome, MD St. Jude Children's Research Hospital
National Cancer Institute (NCI)
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP