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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00898365




Registration number
NCT00898365
Ethics application status
Date submitted
9/05/2009
Date registered
9/05/2009
Date last updated
12/04/2019

Titles & IDs
Public title
Study of Kidney Tumors in Younger Patients
Scientific title
Renal Tumors Classification, Biology, and Banking Study
Secondary ID [1] 0 0
NCI-2009-00416
Secondary ID [2] 0 0
AREN03B2
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clear Cell Sarcoma of the Kidney 0 0
Congenital Mesoblastic Nephroma 0 0
Diffuse Hyperplastic Perilobar Nephroblastomatosis 0 0
Rhabdoid Tumor of the Kidney 0 0
Stage I Kidney Wilms Tumor 0 0
Stage I Renal Cell Cancer AJCC v6 and v7 0 0
Stage II Kidney Wilms Tumor 0 0
Stage II Renal Cell Cancer AJCC v7 0 0
Stage III Kidney Wilms Tumor 0 0
Stage III Renal Cell Cancer AJCC v7 0 0
Stage IV Kidney Wilms Tumor 0 0
Stage IV Renal Cell Cancer AJCC v7 0 0
Stage V Kidney Wilms Tumor 0 0
Condition category
Condition code
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Children's - Other
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Cytology Specimen Collection Procedure
Other interventions - Laboratory Biomarker Analysis

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 interventions: Cytology Specimen Collection Procedure
Correlative studies

Other interventions: Laboratory Biomarker Analysis
Correlative studies

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease-free survival
Timepoint [1] 0 0
Up to 5 years
Primary outcome [2] 0 0
Overall survival
Timepoint [2] 0 0
Up to 5 years
Secondary outcome [1] 0 0
Loss of heterozygosity (LOH testing discontinued as of April 2014)
Timepoint [1] 0 0
Up to 5 years

Eligibility
Key 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
Minimum age
No limit
Maximum age
29 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
John Hunter Children's Hospital - Hunter Regional Mail Centre
Recruitment hospital [2] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [3] 0 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [4] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [5] 0 0
Royal Children's Hospital-Brisbane - Herston
Recruitment hospital [6] 0 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [7] 0 0
Women's and Children's Hospital-Adelaide - North Adelaide
Recruitment hospital [8] 0 0
Monash Medical Center-Clayton Campus - Clayton
Recruitment hospital [9] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [10] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment hospital [11] 0 0
Perth Children's Hospital - Perth
Recruitment postcode(s) [1] 0 0
2310 - Hunter Regional Mail Centre
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
5006 - North Adelaide
Recruitment postcode(s) [7] 0 0
3168 - Clayton
Recruitment postcode(s) [8] 0 0
3052 - Parkville
Recruitment postcode(s) [9] 0 0
6008 - Perth
Recruitment postcode(s) [10] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Alaska
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Arizona
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Arkansas
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California
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Colorado
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Connecticut
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United States of America
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Delaware
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Hawaii
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Idaho
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Illinois
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Indiana
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Iowa
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Kansas
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Kentucky
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Louisiana
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Maine
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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Nebraska
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Nevada
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New Hampshire
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New Jersey
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New Mexico
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New York
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North Carolina
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North Dakota
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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South Dakota
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Tennessee
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Texas
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Utah
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Vermont
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Virginia
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Washington
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West Virginia
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Wisconsin
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Newfoundland and Labrador
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Canada
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Nova Scotia
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Canada
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Ontario
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Quebec
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Canada
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Saskatchewan
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Israel
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Petah Tikua
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New Zealand
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Auckland
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New Zealand
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Christchurch
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New Zealand
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Wellington
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Puerto Rico
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San Juan
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Switzerland
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Bern

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00898365
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Elizabeth Mullen
Address 0 0
Children's Oncology Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00898365