Failure Time Methods for Family Disease Studies
| Tracking Information | |||||
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| First Received Date ICMJE | May 16, 2002 | ||||
| Last Updated Date | June 23, 2005 | ||||
| Start Date ICMJE | April 2001 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00037232 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 | Failure Time Methods for Family Disease Studies | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | To develop statistical methodologies to study genetic and environmental factors in cardiovascular disease, using age at onset data from population-based family studies of disease incidence. |
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| Detailed Description | BACKGROUND: In the study of chronic diseases, both environmental and genetic factors can be influential. In highly common diseases, such as coronary heart disease, genetic effects may be more influential in determining the age of onset of the disease than in determining whether or not one gets the disease. When sufficient information is available, family studies can help localize possible disease genes on the human chromosome through genetic linkage analysis, and familial aggregation of disease can help separate the effects of inheritance, environment and lifestyle on the risk of disease. DESIGN NARRATIVE: The study developed: (1) a general strategy for evaluating the fit of parametric dependence models for familial clustering of ages at disease-onset; (2) a computationally simple method for genetic linkage analysis of age at onset data; (3) application and illustration of recently developed additive frailty models for complex familial dependence structures. Method (1) was applied to a family study of cardiovascular disease and a twin study of appendectomy. Method (2) was applied to ongoing genetic studies conducted at the University of California at San Francisco. Method (3) was applied to a family study of coronary heart disease in Western Australia. Well-documented, user-friendly programs were developed and made publicly available. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Defined Population Observational Model: Natural History |
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| 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 | Not Provided | ||||
| 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 | Completed | ||||
| Enrollment ICMJE | Not Provided | ||||
| Completion Date | March 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | No eligibility criteria |
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00037232 | ||||
| Other Study ID Numbers ICMJE | 1140 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Verification Date | May 2005 | ||||
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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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