Creation of the Biobank Related to Eye Disease (BioBank)
| Tracking Information | |||||
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| First Received Date ICMJE | November 10, 2010 | ||||
| Last Updated Date | November 6, 2012 | ||||
| Start Date ICMJE | June 2009 | ||||
| Estimated Primary Completion Date | June 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To build the platform for a novel application of translational research that links cutting edge molecular laboratory techniques to clinical outcome studies [ Time Frame: unknown ] [ Designated as safety issue: No ] Biobanks can be used for numberous discovery applications such as: identification and structural characterization of human genes, expression analysis, or discovery proteomics. Biological specimens, when coupled with standardized treatment and outcome data, will be essential resources for the identification, characterization and validation of biomarkers that are predictive of disease and treatment. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01240343 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 | Creation of the Biobank Related to Eye Disease | ||||
| Official Title ICMJE | Creation of the Biobank Related to Eye Disease | ||||
| Brief Summary | The purpose of this study is to develop a BioBank (a specialized lab) and collect blood, fluids and/or other tissue samples to study eye diseases. |
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| Detailed Description | The purpose of the Biobank related to eye disease at Beaumont Hospital is to help connect specialties and Specialists with each other, outside traditional limits of hospital or laboratory departments. The specimens (blood, fluids, and/or tissue samples) that will be collected from men, women and children will assist the researchers in a variety of studies on human eye diseases. Research utilizing these specimens will allow for an increased understanding of the etiology, disease process, and response to treatments for various eye diseases, and will provide opportunities to subsequently improve our management decisions. Furthermore, projects that cross over between subspecialties are sparse and that is a limiting factor for the development of research that takes a more comprehensive approach. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: blood, urine other body fluids (i.e. vitreous) |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | All pediatric and adult patients (age 0-99)who are being seen in the eye Dr. office and or having eye surgery |
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| Condition ICMJE | Eye Diseases | ||||
| 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 2020 | ||||
| Estimated Primary Completion Date | June 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: All pediatric and adult patients age 0-99 years - Exclusion Criteria: All patients who do not agree to consent for collection of blood, fluids, tissue. Patients who are cognitively impaired and are not able to verbalize understanding of the risks/benefits. - |
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01240343 | ||||
| Other Study ID Numbers ICMJE | 2009-057 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Kimberly Drenser, William Beaumont Hospitals | ||||
| Study Sponsor ICMJE | Kimberly Drenser | ||||
| Collaborators ICMJE | Vision Research Foundation | ||||
| Investigators ICMJE |
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| Information Provided By | William Beaumont Hospitals | ||||
| Verification Date | May 2011 | ||||
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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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