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OpenTrials
Enrolling by Invitation

NCT Number: NCT05687578

PUER ("Previously Unrecognized Emerging Risks") Life Clinical Study

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.

Enrolling by Invitation

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Key information

Conditions

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Puer Research, LLC

Atlanta, Georgia, 30350, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Measurements Only

Diagnostic Test

This is an observational study only using biospecimen and imaging-based measurements only

Primary outcomes

  1. Biomarkers that exhibit significant change

    Time frame: 12 Months

    The number of biomarkers that exhibit significant change from baseline to any follow-up timepoint, if obtained.

Sponsors and collaborators

Lead sponsor

Puer Research, LLC

Network

Registry information

Official study 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

Acronym: PUER

Important dates

Study start
2023
Primary completion
2029
Study completion
2030
First posted
Jan 18, 2023
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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