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

• Conditions: Aging

• Registration Number: NCT05687578
• Lead Sponsor: Puer Research, LLC

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.

Study Timeline

• Study First Submitted: 2023-01-03
• Study First Submitted QC: 2023-01-17
• Study First Posted: 2023-01-18
• Study Start: 2023-03-27
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-14
• Primary Completion: 2029-01
• Study Completion: 2030-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 10000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biomarkers that exhibit significant change	12 Months	The number of biomarkers that exhibit significant change from baseline to any follow-up timepoint, if obtained.

Trial Locations

Locations (1)

Puer Research, LLC; 🇺🇸 Atlanta, Georgia, United States