Developing Criteria for Cortical Resections
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 7, 2005 | ||||||||
| Last Updated Date | January 8, 2013 | ||||||||
| Start Date ICMJE | September 1998 | ||||||||
| Estimated Primary Completion Date | December 2030 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
measure electrical activity in tissue sample [ Time Frame: at tissue aremoval time ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00152659 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Developing Criteria for Cortical Resections | ||||||||
| Official Title ICMJE | Developing Functional and Structural Criteria for Cortical Resections | ||||||||
| Brief Summary | The purpose of this study is to study how disease processes like tumors or epilepsy spread in the brain. |
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| Detailed Description | The purpose of this study is to study how disease processes like tumors or epilepsy spread in the brain. During surgery small pieces of abnormal (unusual) brain tissue may be removed. We analyze these specimens using more advanced microscopic and electrophysiologic techniques than are usually applied to such tissue specimens. In addition, some tissues can be maintained in laboratory conditions to allow analysis over the longer term. No extra brain tissue is taken to perform these studies. The tissue analysis is performed by the research team and are compared to the routine (normal) electrical recordings that are taken during this type of brain surgery. Currently there are no instructions telling a doctor how much brain tissue should be cut out to prevent the spread of tumors or epilepsy. We are hoping that the results of this study help us to better know how much brain tissue needs to be removed to prevent the spread of tumors or epilepsy. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Time Perspective: Retrospective | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Surgical candidates with epilepsy or brain tumor(s) |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: Tissue sample (procedure/screening)
Tissue sampling |
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| Study Group/Cohort (s) | Not Provided | ||||||||
| 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 | 1000 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | December 2030 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00152659 | ||||||||
| Other Study ID Numbers ICMJE | 9538 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Wim van Drongelen, University of Chicago | ||||||||
| Study Sponsor ICMJE | University of Chicago | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Chicago | ||||||||
| Verification Date | January 2013 | ||||||||
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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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