Study of Kidney Tumors in Younger Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 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: May 12, 2015
Last verified: May 2015

May 9, 2009
May 12, 2015
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 (LOH testing discontinued as of April 2014) [ 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 Younger Patients
Renal Tumors Classification, Biology, and Banking Study

This research trial studies kidney tumors in younger 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.

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. (Loss of heterozygosity [LOH] testing discontinued as of April 2014) 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 stage IV patients.

III. Describe the sensitivity and specificity of abdominal computed tomography (CT) by comparison 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 magnetic resonance imaging (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.

VI. To evaluate the frequency of integrase interactor 1 (INI1) mutations in renal and extrarenal malignant rhabdoid tumor of the kidney and to determine the incidence of germline and inherited versus somatic mutations to facilitate clinical correlations on the companion study AREN0321. (INI1 testing discontinued as of April 2014)

OUTLINE:

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. (LOH and INI1 testing discontinued as of April 2014)

Patients are followed up periodically for 5 years.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Tumor tissue, blood, and urine.

Non-Probability Sample

Patients with the first occurrence of any tumor of the kidney identified on CT scan or MRI.

  • 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
Ancillary-correlative (renal tumor classification, biology)
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. (LOH and INI1 testing discontinued as of April 2014)
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
5000
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])
      • 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 central nervous system [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 or extrarenal neprogenic rests
    • Malignant rhabdoid tumor occurring anywhere outside the Central Nervous System
  • Required specimens, reports, and copies of imaging studies must be available for submission or must become available during the required timeframe
  • 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 hematoxylin and eosin (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)

      • Tissue must be from diagnosis, prior to any chemotherapy or radiation
  • For patients with clinical features and required imaging findings consistent with the eligibility for the bilateral study, AREN0534 (or successor study), confirmed by central review, biopsy is not required; however, if biopsy is done, tissue must be submitted as for other renal tumors, and initial risk assignment will require pathology and surgical rapid central reviews; transmittal form and pathology checklist are also needed
  • 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
Puerto Rico
 
NCT00898365
AREN03B2, NCI-2009-00416, COG-AREN03B2, AREN03B2, AREN03B2, U10CA180886, U10CA098543
Yes
Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Elizabeth Mullen, MD Children's Oncology Group
Children's Oncology Group
May 2015

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