PUER (Previously Unrecognized Emerging Risks) Life Clinical Study

Study Overview
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Brief Summary
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This is a minimal risk, prospective, non-randomized, multi-center population based observational study to establish a physical baseline profile for individual study subjects using various modalities (blood draws, non-invasive imaging, stool samples, saliva samples) and identify deviations through longitudinal monitoring that may develop over time and may be relevant to human health and healthy longevity.

Detailed Description
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The three key elements of the PUER Research protocol include (1) Medical history and physical exam (PE), (2) molecular and laboratory profiling and (3) non-invasive imaging and wearables/ quantified self measurements. The medical history and PE will consist of a comprehensive medical history and physical examination, administered by a trained Research Associate. Laboratory assessments will be conducted using peripheral blood samples, and potentially urine, stool or saliva samples. Non-invasive imaging assessment will consist of magnetic resonance imaging (MRI) and computerized tomography (CT) scans. Other functional assessments, including respiratory, cardiac and other functions, as well as self-quantifiable assessments via wearables will also be conducted. The study will result in longitudinal real-world data collection to inform if any modalities employed here can inform of baseline deviations for individuals. Researchers at study sites will not be blinded to the data being collected during this study.

Official Title
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A Prospective, Non-Randomized, Multi-Center Observational Study to Establish a Physical Baseline Profile for Individual Study Subjects Using Various Modalities and Identify Deviations Via Longitudinal Monitoring That May Develop Over Time

Conditions
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Aging

Intervention / Treatment
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* Diagnostic Test: Diagnostic Only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or non-pregnant female; age 18 to 90 Absence or presence of any medical history or any signs or symptoms of any disease Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at all visits Exclusion Criteria: Unwillingness or inability to participate in the study Unwillingness or inability to provide written Informed Consent Form WOCBP with positive pregnancy test at enrollment or at any visit

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Diagnostic Only|This is an observational study only using non-invasive diagnostic testing|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of biomarkers that exhibit significant change | The number of biomarkers that exhibit significant change from baseline to 12-month follow-up | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aging