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
  Purpose

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.


Condition Intervention
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

Study Type: Observational
Official Title: Renal Tumors Classification, Biology, and Banking Study

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 10-year disease-free survival [ Designated as safety issue: No ]
  • 10-year overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Loss of heterozygosity [ Designated as safety issue: No ]

Study Start Date: February 2006
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 29 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00898365

  Show 215 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
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
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00898365     History of Changes
Other Study ID Numbers: CDR0000459797, COG-AREN03B2
Study First Received: May 9, 2009
Last Updated: November 22, 2012
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage I Wilms tumor
stage II Wilms tumor
stage III Wilms tumor
stage IV Wilms tumor
stage V Wilms tumor
rhabdoid tumor of the kidney
stage I renal cell cancer
stage II renal cell cancer
stage III renal cell cancer
stage IV renal cell cancer
clear cell sarcoma of the kidney
congenital mesoblastic nephroma
diffuse hyperplastic perilobar nephroblastomatosis

Additional relevant MeSH terms:
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013