Trial Review

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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00898365
Ethics application status
Date submitted
9/05/2009
Date registered
12/05/2009
Date last updated
9/08/2024

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:
Adult Cystic Nephroma 0 0
Anaplastic Kidney Wilms Tumor 0 0
Angiolipoma 0 0
Cellular Congenital Mesoblastic Nephroma 0 0
Classic Congenital Mesoblastic Nephroma 0 0
Clear Cell Sarcoma of the Kidney 0 0
Congenital Mesoblastic Nephroma 0 0
Cystic Partially Differentiated Kidney Nephroblastoma 0 0
Diffuse Hyperplastic Perilobar Nephroblastomatosis 0 0
Extrarenal Rhabdoid Tumor 0 0
Kidney Medullary Carcinoma 0 0
Kidney Neoplasm 0 0
Kidney Oncocytoma 0 0
Kidney Wilms Tumor 0 0
Metanephric Adenofibroma 0 0
Metanephric Adenoma 0 0
Metanephric Stromal Tumor 0 0
Metanephric Tumor 0 0
Mixed Congenital Mesoblastic Nephroma 0 0
Ossifying Renal Tumor of Infancy 0 0
Papillary Renal Cell Carcinoma 0 0
Renal Cell Carcinoma 0 0
Renal Cell Carcinoma Associated With Xp11.2 Translocations/TFE3 Gene Fusions 0 0
Rhabdoid Tumor of the Kidney 0 0
Wilms Tumor 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders
Cancer 0 0 0 0
Children's - Other
Cancer 0 0 0 0
Neuroendocrine tumour (NET)
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

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

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, forms, and copies of imaging studies must be available or will become available for submission and the institution must intend on submitting them as described in the protocol procedures
* For ALL patients, (with exception of bilateral, bilaterally predisposed, multicentric, 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 (including from sampled lymph nodes, if patient had upfront nephrectomy)

* * Tissue must be from diagnosis, prior to any renal tumor directed chemotherapy or radiation (only exception is for presumed favorable histology Wilms tumor [FHWT] patients discovered to have diffuse anaplastic Wilms tumor [DAWT] at delayed nephrectomy and plan to enroll at delayed nephrectomy)
* Representative formalin-fixed paraffin-embedded tissue block or if a block is unavailable, 10 unstained slides from a representative block of tumor, if available.

* Tissue must be from diagnosis, prior to any renal tumor directed chemotherapy or radiation (only exception is for presumed FHWT patients discovered to have DAWT at delayed nephrectomy and plan to enroll at delayed nephrectomy)
* Institutional pathology report, Specimen Transmittal Form, and Pre-Treatment Pathology Checklist
* Copies of images and institutional reports of CT and/or MRI abdomen and pelvis, and Pre Treatment Imaging Checklist
* Copies of images and institutional report of chest CT for all malignant tumors
* Institutional surgical report(s) and Pre-Treatment Surgical Checklist
* CRFs: Staging Checklist and Metastatic Disease Form (if metastatic disease is noted on imaging)

* Patients with bilateral, bilaterally predisposed, multicentric, or unilateral tumor in solitary kidney planning to enroll without biopsy via imaging only - these patients will not have central review or have a risk assignment issued, but may contribute to specimen banking for future research. 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. The Specimen Transmittal Form and Pre Treatment Pathology Checklist are also needed.
* Please note: if the above required items are not received within 120 days of study enrollment, the patient will be considered off study
* 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
Sex
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
27/02/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
8000
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
Country [2] 0 0
United States of America
State/province [2] 0 0
Alaska
Country [3] 0 0
United States of America
State/province [3] 0 0
Arizona
Country [4] 0 0
United States of America
State/province [4] 0 0
Arkansas
Country [5] 0 0
United States of America
State/province [5] 0 0
California
Country [6] 0 0
United States of America
State/province [6] 0 0
Colorado
Country [7] 0 0
United States of America
State/province [7] 0 0
Connecticut
Country [8] 0 0
United States of America
State/province [8] 0 0
Delaware
Country [9] 0 0
United States of America
State/province [9] 0 0
District of Columbia
Country [10] 0 0
United States of America
State/province [10] 0 0
Florida
Country [11] 0 0
United States of America
State/province [11] 0 0
Georgia
Country [12] 0 0
United States of America
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Hawaii
Country [13] 0 0
United States of America
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Idaho
Country [14] 0 0
United States of America
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Illinois
Country [15] 0 0
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Indiana
Country [16] 0 0
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Iowa
Country [17] 0 0
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Kansas
Country [18] 0 0
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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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United States of America
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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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United States of America
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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
Country [52] 0 0
Canada
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Manitoba
Country [53] 0 0
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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Canada
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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
State/province [62] 0 0
San Juan
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Switzerland
State/province [63] 0 0
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Elizabeth A 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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00898365