Study of Kidney Tumors in Young Patients
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| First Received Date ICMJE | May 9, 2009 | ||||||||
| Last Updated Date | November 22, 2012 | ||||||||
| Start Date ICMJE | February 2006 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00898365 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Loss of heterozygosity [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Study of Kidney Tumors in Young Patients | ||||||||
| Official Title ICMJE | Renal Tumors Classification, Biology, and Banking Study | ||||||||
| Brief Summary | RATIONALE: 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 DNA and identify biomarkers related to cancer. It may also help the study of cancer in the future. PURPOSE: This laboratory study is looking at kidney tumors in young patients. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a multicenter study. 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. Patients are followed periodically for 5 years. PROJECTED ACCRUAL: There are no sample size goals for this study. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Not Provided | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Not Provided | ||||||||
| Study Population | Not Provided | ||||||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Khanna G, Rosen N, Anderson JR, Ehrlich PF, Dome JS, Gow KW, Perlman E, Barnhart D, Karolczuk K, Grundy P. Evaluation of diagnostic performance of CT for detection of tumor thrombus in children with Wilms tumor: A report from the Children's Oncology Group. Pediatr Blood Cancer. 2011 Jun 14; [Epub ahead of print] | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | Not Provided | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Both | ||||||||
| Ages | up to 29 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Not Provided | ||||||||
| Location Countries ICMJE | United States, Australia, Canada, Israel, New Zealand, Puerto Rico, Switzerland | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00898365 | ||||||||
| Other Study ID Numbers ICMJE | CDR0000459797, COG-AREN03B2 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | Children's Oncology Group | ||||||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||
| Verification Date | November 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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