Trial record 1 of 1 for:    AREN03B2
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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
  Purpose

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.


Condition Intervention
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
Other: cytology specimen collection procedure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Renal Tumors Classification, Biology, and Banking Study

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Loss of heterozygosity (LOH testing discontinued as of April 2014) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Tumor tissue, blood, and urine.


Estimated Enrollment: 5000
Study Start Date: February 2006
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)
Other: laboratory biomarker analysis
Correlative studies
Other: cytology specimen collection procedure
Correlative studies
Other Name: cytologic sampling

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 29 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 231 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Elizabeth Mullen, MD Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00898365     History of Changes
Other Study ID Numbers: AREN03B2, NCI-2009-00416, COG-AREN03B2, AREN03B2, AREN03B2, U10CA180886, U10CA098543
Study First Received: May 9, 2009
Last Updated: May 12, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Hyperplasia
Kidney Neoplasms
Neoplasms
Nephroma, Mesoblastic
Rhabdoid Tumor
Sarcoma, Clear Cell
Wilms Tumor
Adenocarcinoma
Carcinoma
Genetic Diseases, Inborn
Kidney Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Complex and Mixed
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms, Glandular and Epithelial
Neoplastic Syndromes, Hereditary
Pathologic Processes
Sarcoma
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on August 30, 2015