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

NCT ID: NCT05687578

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-27
• Study Completion Date: 2030-01-31

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.

Conditions

Aging

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Measurements Only

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

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Puer Research, LLC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Szilard Voros, MD

Role: PRINCIPAL_INVESTIGATOR

Puer Life

Locations

Puer Research, LLC

Atlanta, Georgia, United States

Countries

United States

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Provided Documents

Document Type: Study Protocol

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Document Type: Informed Consent Form

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Other Identifiers

PLI001

Identifier Type: -

Identifier Source: org_study_id