Study of Kidney Tumors in Young Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00898365
First received: May 9, 2009
Last updated: August 5, 2014
Last verified: August 2014

May 9, 2009
August 5, 2014
February 2006
January 2100   (final data collection date for primary outcome measure)
  • Disease-free survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • 10-year disease-free survival [ Designated as safety issue: No ]
  • 10-year overall survival [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00898365 on ClinicalTrials.gov Archive Site
Loss of heterozygosity [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
Loss of heterozygosity [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of Kidney Tumors in Young Patients
Renal Tumors Classification, Biology, and Banking Study

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.

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.

Observational
Time Perspective: Prospective
Not Provided

Tumor tissue, blood, and urine samples

Non-Probability Sample

Patients newly diagnosed with Wilm's Tumor

  • 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
  • Other: laboratory biomarker analysis
    Correlative studies
  • Other: cytology specimen collection procedure
    Correlative studies
    Other Name: cytologic sampling
Observational
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.
Interventions:
  • Other: laboratory biomarker analysis
  • Other: cytology specimen collection procedure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
January 2100   (final data collection date for primary outcome measure)

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
Both
up to 29 Years
No
United States,   Australia,   Canada,   Israel,   New Zealand,   Puerto Rico,   Switzerland
 
NCT00898365
AREN03B2, NCI-2009-00416, CDR0000459797, COG-AREN03B2, U10CA098543
No
Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Elizabeth Mullen Children's Oncology Group
Children's Oncology Group
August 2014

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