The Healthy Elderly Longevity Cohort (Wellderly)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01004133 |
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Recruitment Status :
Recruiting
First Posted : October 29, 2009
Last Update Posted : March 18, 2020
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| Tracking Information | |||||||||
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| First Submitted Date | October 27, 2009 | ||||||||
| First Posted Date | October 29, 2009 | ||||||||
| Last Update Posted Date | March 18, 2020 | ||||||||
| Study Start Date | August 2007 | ||||||||
| Estimated Primary Completion Date | January 2030 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Biorepository Creation [ Time Frame: ten years ] Create a biorepository from participants' blood and/or saliva donations we will ultimately be able to define genes for various diseases and understand health
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| Original Primary Outcome Measures | Not Provided | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | The Healthy Elderly Longevity Cohort | ||||||||
| Official Title | The Healthy Elderly Longevity Cohort | ||||||||
| Brief Summary | With the completion of the human genome project, investigators can now explore new questions in human biology. Previously human genetics focused on highly penetrant, Mendelian traits; however, now rare and common variants can be discovered that affect "common" diseases that have multi-gene architecture with variable penetrance such as breast cancer, diabetes mellitus, and coronary artery disease. This change took place because investigators now have the tools to illuminate the whole genome at once to discover the genetic variants responsible for different disease phenotypes through statistical differences between populations. Besides disease phenotypes, health can be considered a human phenotype that can be studied. Health is not merely the absence of disease but may be viewed as a dynamic ongoing interplay between the environment and the genome to maintain homeostasis. Individuals often attempt to optimize environmental conditions according to ones genome to maximize their health. All individuals possess potentially beneficial and harmful variants depending on the environment. How this dynamic interplay occurs between the genome and environment requires understanding the boundary conditions of the genetic architecture of health and disease and then modeling the system to simulate the observed data. The aging process also affects health. Aging involves a loss of the normal coping responses to internal and external environmental stressors or signals. Investigators now have the tools to uncover from the bottom up the mechanisms involved in maintaining the ability to overcome environmental conditions that can affect health. Against this genomic breakthrough of whole genome association studies, the demographics in the United States are quickly changing. The older population (age > 65 years) in 2030 is projected to be twice as large as in 2000 representing nearly 20 percent of the total US population. The first baby boomers turn 65 in 2011 and will challenge all facets of health care in the coming decades. The demographic changes underscore the need to understand the mechanisms that promote health and disease in this cohort. Genomic discoveries will help individuals and may reduce medical costs and benefit society. In summary, the objective of this study is to obtain blood and/or saliva samples in order to help model health and disease phenotypes through population genomics. The blood and/or saliva samples may allow for participants' entire genomes to be sequenced if such comprehensive analysis becomes feasible and economical. |
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| Detailed Description | Not Provided | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Other Time Perspective: Other |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: A single blood specimen or saliva specimen is collected from each subject. If blood is collected, approximately thirty eight milliliters of blood will be dispensed as follows: 3 x 8.5 mls DNA Tubes 1 x 2.5 mls RNA tube 1 x 10 mls EBV tube (EDTA) for immortalized cell lines |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | General outpatient and community population. | ||||||||
| Condition | Healthy | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Subjects 80 years of age or older without chronic diseases. | ||||||||
| 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 | Recruiting | ||||||||
| Estimated Enrollment |
5000 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | January 2030 | ||||||||
| Estimated Primary Completion Date | January 2030 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 80 Years and older (Older Adult) | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts |
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| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT01004133 | ||||||||
| Other Study ID Numbers | HSC 07-4789 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product | Not Provided | ||||||||
| IPD Sharing Statement | Not Provided | ||||||||
| Current Responsible Party | Eric Topol, MD, Scripps Translational Science Institute | ||||||||
| Original Responsible Party | Eric J. Topol, MD, Scripps Genomic Medicine | ||||||||
| Current Study Sponsor | Scripps Translational Science Institute | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators | Not Provided | ||||||||
| PRS Account | Scripps Translational Science Institute | ||||||||
| Verification Date | March 2020 | ||||||||