The Genetics of Chiari Type I Malformation
| Tracking Information | |||||
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| First Received Date ICMJE | February 1, 2010 | ||||
| Last Updated Date | January 22, 2013 | ||||
| Start Date ICMJE | June 2009 | ||||
| Estimated Primary Completion Date | June 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Genetic factors contributing to Chiari Type I malformation [ Time Frame: end of study ] [ Designated as safety issue: No ] This study aims to identify genetic factors that contribute to or cause Chiari Type I malformation. |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01060800 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 | The Genetics of Chiari Type I Malformation | ||||
| Official Title ICMJE | The Genetics of Chiari Type I Malformation (CMI) With or Without Syringomyelia | ||||
| Brief Summary | The Duke Center for Human Genetics, is investigating the hereditary basis of Chiari type I malformations with or without syringomyelia (CM1/S). Our research is aimed at learning if CM1/S is indeed caused by factors inherited through the family and, if so, which genes are involved. |
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| Detailed Description | The Duke Center for Human Genetics is actively recruiting families who have TWO OR MORE family members with Chiari Type I Malformations, with or without syringomyelia. These family members must be related to each other by blood, and BOTH must be willing to participate. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Family-Based Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: Whole blood, serum, DNA |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Families who have TWO OR MORE family members with Chiari Type I Malformation, with or without syringomyelia. These family members must be related to each other by blood, and BOTH must be willing to participate. |
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| Condition ICMJE | Chiari Type I Malformation | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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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 | 2000 | ||||
| Estimated Completion Date | June 2014 | ||||
| Estimated Primary Completion Date | June 2014 (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 | NCT01060800 | ||||
| Other Study ID Numbers ICMJE | Pro00011231 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Duke University | ||||
| Study Sponsor ICMJE | Duke University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Duke University | ||||
| 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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