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

Aging Clinical Trial

— PUER  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05687578
• Other study ID #: PLI001
• Status: Enrolling by invitation
• Start date: March 29, 2023
• Est. completion date: January 2030

Study information

• Verified date: March 2023
• Source: Puer Research, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The three key elements of the PUER Research protocol include (1) Medical history and physical exam (PE), (2) molecular and laboratory profiling and (3) non-invasive imaging and wearables/ "quantified self" measurements. The medical history and PE will consist of a comprehensive medical history and physical examination, administered by a trained Research Associate. Laboratory 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. Other functional assessments, including respiratory, cardiac and other functions, as well as self-quantifiable assessments via wearables will also be conducted.

The study will result in longitudinal real-world 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10000
• Est. completion date: January 2030
• Est. primary completion date: January 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging

Intervention

Diagnostic Test:
• Diagnostic Only
This is an observational study only using non-invasive diagnostic testing

Locations

Country	Name	City	State
United States	Puer Research	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Puer Research, LLC

Country where clinical trial is conducted

United States, 

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of biomarkers that exhibit significant change	The number of biomarkers that exhibit significant change from baseline to 12-month follow-up	12 Months