Study of Stored Tumor Samples in Young Patients With Brain Tumors
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| First Received Date ICMJE | May 9, 2009 | ||||||||
| Last Updated Date | July 6, 2012 | ||||||||
| Start Date ICMJE | November 2004 | ||||||||
| Estimated Primary Completion Date | November 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Relationship between molecular abnormalities and tumor histologic and clinical characteristics [ Time Frame: 10 Years ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Relationship between molecular abnormalities and tumor histologic and clinical characteristics [ Designated as safety issue: No ] | ||||||||
| Change History | Complete list of historical versions of study NCT00897286 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Current Other Outcome Measures ICMJE | |||||||||
| Original Other Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Study of Stored Tumor Samples in Young Patients With Brain Tumors | ||||||||
| Official Title ICMJE | Molecular and Histopathologic Characterization of Atypical Teratoid Rhabdoid Tumors, Choroid Plexus Carcinomas, Ependymomas Adn Medulloblastoma/PNET of the Pediatric CNS | ||||||||
| Brief Summary | This laboratory study is looking at stored tumor samples in young patients with brain tumors. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. |
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| Detailed Description | The overall objective of this non-therapeutic protocol is to identify molecular abnormalities within prospectively treated pediatric CNS Atypical Teratoid Rhabdoid Tumors (ATRT) and Choroid Plexus Carcinomas (CPC), Ependymoma and define the relationship between these abnormalities and tumor histologic and clinical characteristics. This objective will be achieved by applying state-of-the-art DNA, RNA and protein analysis tools to the study of fresh frozen, fixed and cultured tumor cells. The establishment of cell cultures from each tumor sample will also allow for in vitro analysis of tumor cell growth, signaling and therapeutic response. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Biospecimen | Retention: Samples With DNA Description: Fresh frozen, fixed and cultured tumor cells collected prospectively from a clinically well characterized patient cohort. |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Participants will have ATRT, CPC, medulloblastoma/PNET or ependymoma of the CNS as documented by the local neuropathologist. All studies will be conducted using tumor material collected prospectively from a clinically well characterized patient cohort. |
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| Condition ICMJE | Brain and Central Nervous System Tumors | ||||||||
| Intervention ICMJE | |||||||||
| Study Group/Cohort (s) | Tumor/Tissue Sample
Tumor material collected prospectively from a clinically well characterized patient cohort |
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| Publications * | |||||||||
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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 | ||||||||
| Estimated Enrollment ICMJE | 200 | ||||||||
| Estimated Completion Date | November 2014 | ||||||||
| Estimated Primary Completion Date | November 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
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| Gender | Both | ||||||||
| Ages | up to 21 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00897286 | ||||||||
| Other Study ID Numbers ICMJE | NBTP01 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | St. Jude Children's Research Hospital | ||||||||
| Study Sponsor ICMJE | St. Jude Children's Research Hospital | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | St. Jude Children's Research Hospital | ||||||||
| Verification Date | July 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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