Clinical trial NCT05687578: PUER ("Previously Unrecognized Emerging Risks") Life Clinical Study
Official title: 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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Aging
Keywords: Aging
Lead sponsor: Puer Research, LLC
Sponsor class: NETWORK
First posted: 2023-01-18
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a prospective, population-based observational study. Participants may be recruited from clinical sites that are actively participating in the PUER Research comprehensive evaluation model. Participants and all participating health care providers are unblinded.

Brief summary: 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: The two key elements of the PUER Research protocol include (1) molecular and laboratory profiling and (2) non-invasive imaging and wearables/ "quantified self" measurements. All elements are optional. Molecular 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, ultrasound, and x-ray. All imaging modalities are optional. Other functional assessments, including respiratory, cardiac and other functions, as well as self-quantifiable assessments via wearables, may also be conducted and are optional.

The study will result in longitudinal 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.

Eligibility criteria: 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

Primary outcomes:
measure: Biomarkers that exhibit significant change
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Puer Research, LLC
state: Georgia
Study officials:
affiliation: Puer Life
name: Szilard Voros, MD
role: PRINCIPAL_INVESTIGATOR
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