Clinical trial NCT06802029: PUER ("Previously Unrecognized Emerging Risks") Life Clinical Study (PUER) in Ages 6 Through 18
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 for Participants Ages 6 Through 18
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Aging
Keywords: Aging
Lead sponsor: Puer Research, LLC
Sponsor class: NETWORK
First posted: 2025-01-30
Enrollment: 10000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male or non-pregnant female; age 6 to less than 18.

Brief summary: The goal of this observational study is to learn about changes in health in children that develop over time that may impact overall health and a healthy lifespan. The main questions it aims to answer are:

* What are the changes in health that impact overall health and lifespan in children; and
* What test(s) are best at finding changes in health in children?

Detailed description: The two parts of the PUER Research study include (1) Baseline health assessment and (2) blood tests including genetic, molecular, and laboratory profiling. The Baseline assessment will consist of a health history questionnaire interview. Genetic assessment will be conducted using peripheral blood samples. Molecular and laboratory assessments will be conducted using peripheral blood samples and, potentially, urine, stool, and/or saliva samples.

The study will result in cross-sectional and longitudinal real world data collection to inform if any tests used can inform of health changes for individuals and may predict long-term health outcomes. Researchers at study sites will not be blinded to the data being collected during this study.

Eligibility criteria: Inclusion Criteria:

To participate in the study, patients must meet the following criteria:

1. Male or non-pregnant female; age 6 to less than 18.
2. Females of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at all visits.
3. Presence of

   1. At least one pathogenic genetic variant in a biological parent, which is annotated as pathogenic in at least one public database, such as dbSNP, ClinVar, VEP (variant effect predictor), etc.; OR
   2. Presence of unexplained disease, illness, trait, or phenotype.
4. Approval is at the sole discretion of the sponsor.

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from study participation:

1. Unwillingness or inability to participate in the study.
2. Unwillingness or inability to provide assent as per inclusion criterion #1, including those who lack the capacity to provide assent and will obtain 18 years of age prior to completion of the study.
3. WOCBP a with positive pregnancy test at enrollment or at any visit.

Primary outcomes:
measure: New deviations: 12 months
timeFrame: 12 months
measure: New deviations: 6 months
timeFrame: 6 months
measure: New deviations: 18 months
timeFrame: 18 months
measure: New deviations: 24 months
timeFrame: 24 months
measure: New deviations: 36 months
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
measure: Medications
timeFrame: 6 months, 12 months, 18 months, 24 months, and 36 months after enrollment.
measure: Dietary supplements
timeFrame: 6 months, 12 months, 18 months, 24 months, and 36 months after enrollment.
Locations:
city: Atlanta
country: United States
facility: Puer Research, LLC
state: Georgia
Study officials:
affiliation: Principal Investigator
name: Szilard Voros, MD
role: PRINCIPAL_INVESTIGATOR
References:
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