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

October 9, 2024 updated by: Puer Research, LLC

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30350
        • Puer Research, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Puer Research, LLC

Investigators

  • Principal Investigator: Szilard Voros, MD, Puer Life

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2023

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

January 3, 2023

First Submitted That Met QC Criteria

January 17, 2023

First Posted (Actual)

January 18, 2023

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 9, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PLI001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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