Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    AREN03B2
Previous Study | Return to List | Next Study

Study of Kidney Tumors in Younger Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00898365
Recruitment Status : Suspended (Other - Pending evaluation of patients currently enrolled)
First Posted : May 12, 2009
Last Update Posted : August 22, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Tracking Information
First Submitted Date May 9, 2009
First Posted Date May 12, 2009
Last Update Posted Date August 22, 2019
Actual Study Start Date February 27, 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: July 8, 2013)
  • Disease-free survival [ Time Frame: Up to 5 years ]
  • Overall survival [ Time Frame: Up to 5 years ]
Original Primary Outcome Measures
 (submitted: May 9, 2009)
  • 10-year disease-free survival
  • 10-year overall survival
Change History
Current Secondary Outcome Measures
 (submitted: May 12, 2015)
Loss of heterozygosity (LOH testing discontinued as of April 2014) [ Time Frame: Up to 5 years ]
Original Secondary Outcome Measures
 (submitted: May 9, 2009)
Loss of heterozygosity
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of Kidney Tumors in Younger Patients
Official Title Renal Tumors Classification, Biology, and Banking Study
Brief Summary 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.
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Tumor, blood, and urine samples
Sampling Method Non-Probability Sample
Study Population Patients newly diagnosed with kidney tumors
Condition
  • Adult Cystic Nephroma
  • Anaplastic Kidney Wilms Tumor
  • Angiolipoma
  • Cellular Congenital Mesoblastic Nephroma
  • Classic Congenital Mesoblastic Nephroma
  • Clear Cell Sarcoma of the Kidney
  • Congenital Mesoblastic Nephroma
  • Cystic Partially Differentiated Kidney Nephroblastoma
  • Diffuse Hyperplastic Perilobar Nephroblastomatosis
  • Extrarenal Rhabdoid Tumor
  • Kidney Medullary Carcinoma
  • Kidney Neoplasm
  • Kidney Oncocytoma
  • Kidney Wilms Tumor
  • Metanephric Adenofibroma
  • Metanephric Adenoma
  • Metanephric Stromal Tumor
  • Metanephric Tumor
  • Mixed Congenital Mesoblastic Nephroma
  • Ossifying Renal Tumor of Infancy
  • Papillary Renal Cell Carcinoma
  • Renal Cell Carcinoma
  • Renal Cell Carcinoma Associated With Xp11.2 Translocations/TFE3 Gene Fusions
  • Rhabdoid Tumor of the Kidney
  • Wilms Tumor
Intervention
  • Other: Cytology Specimen Collection Procedure
    Correlative studies
    Other Name: Cytologic Sampling
  • Other: Laboratory Biomarker Analysis
    Correlative studies
Study Groups/Cohorts 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: Cytology Specimen Collection Procedure
  • Other: Laboratory Biomarker Analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Suspended
Estimated Enrollment
 (submitted: August 20, 2019)
6573
Original Enrollment Not Provided
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 29 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   Canada,   Israel,   New Zealand,   Puerto Rico,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00898365
Other Study ID Numbers AREN03B2
NCI-2009-00416 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-AREN03B2
CDR0000459797
AREN03B2 ( Other Identifier: Childrens Oncology Group )
AREN03B2 ( Other Identifier: CTEP )
U10CA180886 ( U.S. NIH Grant/Contract )
U10CA098543 ( U.S. NIH Grant/Contract )
UG1CA189958 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Children's Oncology Group
Study Sponsor Children's Oncology Group
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Elizabeth A Mullen Children's Oncology Group
PRS Account Children's Oncology Group
Verification Date August 2019