Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05687578
Other study ID # PLI001
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)

Amendola LM, Dorschner MO, Robertson PD, Salama JS, Hart R, Shirts BH, Murray ML, Tokita MJ, Gallego CJ, Kim DS, Bennett JT, Crosslin DR, Ranchalis J, Jones KL, Rosenthal EA, Jarvik ER, Itsara A, Turner EH, Herman DS, Schleit J, Burt A, Jamal SM, Abrudan JL, Johnson AD, Conlin LK, Dulik MC, Santani A, Metterville DR, Kelly M, Foreman AK, Lee K, Taylor KD, Guo X, Crooks K, Kiedrowski LA, Raffel LJ, Gordon O, Machini K, Desnick RJ, Biesecker LG, Lubitz SA, Mulchandani S, Cooper GM, Joffe S, Richards CS, Yang Y, Rotter JI, Rich SS, O'Donnell CJ, Berg JS, Spinner NB, Evans JP, Fullerton SM, Leppig KA, Bennett RL, Bird T, Sybert VP, Grady WM, Tabor HK, Kim JH, Bamshad MJ, Wilfond B, Motulsky AG, Scott CR, Pritchard CC, Walsh TD, Burke W, Raskind WH, Byers P, Hisama FM, Rehm H, Nickerson DA, Jarvik GP. Actionable exomic incidental findings in 6503 participants: challenges of variant classification. Genome Res. 2015 Mar;25(3):305-15. doi: 10.1101/gr.183483.114. Epub 2015 Jan 30. — View Citation

Arnoldi E, Gebregziabher M, Schoepf UJ, Goldenberg R, Ramos-Duran L, Zwerner PL, Nikolaou K, Reiser MF, Costello P, Thilo C. Automated computer-aided stenosis detection at coronary CT angiography: initial experience. Eur Radiol. 2010 May;20(5):1160-7. doi: 10.1007/s00330-009-1644-7. Epub 2009 Nov 5. — View Citation

Assarsson E, Lundberg M, Holmquist G, Bjorkesten J, Thorsen SB, Ekman D, Eriksson A, Rennel Dickens E, Ohlsson S, Edfeldt G, Andersson AC, Lindstedt P, Stenvang J, Gullberg M, Fredriksson S. Homogenous 96-plex PEA immunoassay exhibiting high sensitivity, specificity, and excellent scalability. PLoS One. 2014 Apr 22;9(4):e95192. doi: 10.1371/journal.pone.0095192. eCollection 2014. — View Citation

Bennuru S, Lustigman S, Abraham D, Nutman TB. Metabolite profiling of infection-associated metabolic markers of onchocerciasis. Mol Biochem Parasitol. 2017 Jul;215:58-69. doi: 10.1016/j.molbiopara.2017.01.008. Epub 2017 Feb 8. — View Citation

Bromberg Y. Building a genome analysis pipeline to predict disease risk and prevent disease. J Mol Biol. 2013 Nov 1;425(21):3993-4005. doi: 10.1016/j.jmb.2013.07.038. Epub 2013 Aug 5. — View Citation

Chong CA, Tomlinson G, Chodirker L, Figdor N, Uster M, Naglie G, Krahn MD. An unadjusted NNT was a moderately good predictor of health benefit. J Clin Epidemiol. 2006 Mar;59(3):224-33. doi: 10.1016/j.jclinepi.2005.08.005. — View Citation

Crick F. Central dogma of molecular biology. Nature. 1970 Aug 8;227(5258):561-3. doi: 10.1038/227561a0. No abstract available. — View Citation

David CEB, Lucas AMB, Cunha PLO, Viana YIP, Yoshinaga MY, Miyamoto S, Filho ABC, Varela ALN, Kowaltowski AJ, Facundo HT. Calorie restriction changes lipidomic profiles and maintains mitochondrial function and redox balance during isoproterenol-induced cardiac hypertrophy. J Physiol Biochem. 2022 Feb;78(1):283-294. doi: 10.1007/s13105-021-00863-4. Epub 2022 Jan 13. — View Citation

Design and baseline results of the Scandinavian Simvastatin Survival Study of patients with stable angina and/or previous myocardial infarction. Am J Cardiol. 1993 Feb 15;71(5):393-400. doi: 10.1016/0002-9149(93)90438-i. — View Citation

Dorschner MO, Amendola LM, Turner EH, Robertson PD, Shirts BH, Gallego CJ, Bennett RL, Jones KL, Tokita MJ, Bennett JT, Kim JH, Rosenthal EA, Kim DS; National Heart, Lung, and Blood Institute Grand Opportunity Exome Sequencing Project; Tabor HK, Bamshad MJ, Motulsky AG, Scott CR, Pritchard CC, Walsh T, Burke W, Raskind WH, Byers P, Hisama FM, Nickerson DA, Jarvik GP. Actionable, pathogenic incidental findings in 1,000 participants' exomes. Am J Hum Genet. 2013 Oct 3;93(4):631-40. doi: 10.1016/j.ajhg.2013.08.006. Epub 2013 Sep 19. — View Citation

Fest J, Vijfhuizen LS, Goeman JJ, Veth O, Joensuu A, Perola M, Mannisto S, Ness-Jensen E, Hveem K, Haller T, Tonisson N, Mikkel K, Metspalu A, van Duijn CM, Ikram A, Stricker BH, Ruiter R, van Eijck CHJ, van Ommen GB, 't Hoen PAC. Search for Early Pancreatic Cancer Blood Biomarkers in Five European Prospective Population Biobanks Using Metabolomics. Endocrinology. 2019 Jul 1;160(7):1731-1742. doi: 10.1210/en.2019-00165. — View Citation

Ganz P, Heidecker B, Hveem K, Jonasson C, Kato S, Segal MR, Sterling DG, Williams SA. Development and Validation of a Protein-Based Risk Score for Cardiovascular Outcomes Among Patients With Stable Coronary Heart Disease. JAMA. 2016 Jun 21;315(23):2532-41. doi: 10.1001/jama.2016.5951. — View Citation

Gold L, Ayers D, Bertino J, Bock C, Bock A, Brody EN, Carter J, Dalby AB, Eaton BE, Fitzwater T, Flather D, Forbes A, Foreman T, Fowler C, Gawande B, Goss M, Gunn M, Gupta S, Halladay D, Heil J, Heilig J, Hicke B, Husar G, Janjic N, Jarvis T, Jennings S, Katilius E, Keeney TR, Kim N, Koch TH, Kraemer S, Kroiss L, Le N, Levine D, Lindsey W, Lollo B, Mayfield W, Mehan M, Mehler R, Nelson SK, Nelson M, Nieuwlandt D, Nikrad M, Ochsner U, Ostroff RM, Otis M, Parker T, Pietrasiewicz S, Resnicow DI, Rohloff J, Sanders G, Sattin S, Schneider D, Singer B, Stanton M, Sterkel A, Stewart A, Stratford S, Vaught JD, Vrkljan M, Walker JJ, Watrobka M, Waugh S, Weiss A, Wilcox SK, Wolfson A, Wolk SK, Zhang C, Zichi D. Aptamer-based multiplexed proteomic technology for biomarker discovery. PLoS One. 2010 Dec 7;5(12):e15004. doi: 10.1371/journal.pone.0015004. — View Citation

Guttmacher AE, Collins FS. Welcome to the genomic era. N Engl J Med. 2003 Sep 4;349(10):996-8. doi: 10.1056/NEJMe038132. No abstract available. — View Citation

Han X, Aslanian A, Yates JR 3rd. Mass spectrometry for proteomics. Curr Opin Chem Biol. 2008 Oct;12(5):483-90. doi: 10.1016/j.cbpa.2008.07.024. — View Citation

Hayden EC. Technology: The $1,000 genome. Nature. 2014 Mar 20;507(7492):294-5. doi: 10.1038/507294a. No abstract available. — View Citation

Lemaitre G, Marti R, Freixenet J, Vilanova JC, Walker PM, Meriaudeau F. Computer-Aided Detection and diagnosis for prostate cancer based on mono and multi-parametric MRI: a review. Comput Biol Med. 2015 May;60:8-31. doi: 10.1016/j.compbiomed.2015.02.009. Epub 2015 Feb 20. — View Citation

Li J, Huang A, Yao J, Liu J, Van Uitert RL, Petrick N, Summers RM. Optimizing computer-aided colonic polyp detection for CT colonography by evolving the Pareto fronta. Med Phys. 2009 Jan;36(1):201-12. doi: 10.1118/1.3040177. — View Citation

Netto, G., & Kaul, K, e. (2019). Genomic Applications in Pathology. Springer International Publishing

Onal S, Lai-Yuen S, Bao P, Weitzenfeld A, Hart S. Fully automated localization of multiple pelvic bone structures on MRI. Annu Int Conf IEEE Eng Med Biol Soc. 2014;2014:3353-6. doi: 10.1109/EMBC.2014.6944341. — View Citation

Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet. 1994 Nov 19;344(8934):1383-9. — View Citation

Rosenberg S, Elashoff MR, Beineke P, Daniels SE, Wingrove JA, Tingley WG, Sager PT, Sehnert AJ, Yau M, Kraus WE, Newby LK, Schwartz RS, Voros S, Ellis SG, Tahirkheli N, Waksman R, McPherson J, Lansky A, Winn ME, Schork NJ, Topol EJ; PREDICT (Personalized Risk Evaluation and Diagnosis in the Coronary Tree) Investigators. Multicenter validation of the diagnostic accuracy of a blood-based gene expression test for assessing obstructive coronary artery disease in nondiabetic patients. Ann Intern Med. 2010 Oct 5;153(7):425-34. doi: 10.7326/0003-4819-153-7-201010050-00005. — View Citation

Scaria V. Personal genomes to precision medicine. Mol Cytogenet. 2014 Jan 21;7(Suppl 1 Proceedings of the International Conference on Human):I28. doi: 10.1186/1755-8166-7-S1-I28. eCollection 2014. No abstract available. — View Citation

Schork NJ. Personalized medicine: Time for one-person trials. Nature. 2015 Apr 30;520(7549):609-11. doi: 10.1038/520609a. No abstract available. — View Citation

Uppot, R.N., Boas, G., & Flores, E. (2018). Current Developments in Artificial Intelligence and Diagnostic Imaging

Yang Q, Li L, Zhang J, Shao G, Zhang C, Zheng B. Computer-aided diagnosis of breast DCE-MRI images using bilateral asymmetry of contrast enhancement between two breasts. J Digit Imaging. 2014 Feb;27(1):152-60. doi: 10.1007/s10278-013-9617-4. — View Citation

Yet I, Menni C, Shin SY, Mangino M, Soranzo N, Adamski J, Suhre K, Spector TD, Kastenmuller G, Bell JT. Genetic Influences on Metabolite Levels: A Comparison across Metabolomic Platforms. PLoS One. 2016 Apr 13;11(4):e0153672. doi: 10.1371/journal.pone.0153672. eCollection 2016. — View Citation

Zhu B, Liu JZ, Cauley SF, Rosen BR, Rosen MS. Image reconstruction by domain-transform manifold learning. Nature. 2018 Mar 21;555(7697):487-492. doi: 10.1038/nature25988. — View Citation

* Note: There are 28 references in allClick 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
See also
  Status Clinical Trial Phase
Completed NCT05433233 - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension N/A
Recruiting NCT06032065 - Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD) Phase 3
Completed NCT05293730 - Trial of the Impact of the Electronic Frailty Integrated With Social Needs N/A
Recruiting NCT03932162 - Gene Expression Changes In Young and Geriatric Skin Early Phase 1
Completed NCT04064528 - Effects of Age on Amino Acid Delivery to Tendon N/A
Completed NCT03366129 - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Completed NCT06029920 - Influence of Overground Walking on Biomarkers, Cognitive Function, and Quality of Life in Elderly With Mild Cognitive Impairment N/A
Recruiting NCT05566938 - Study to Design a Precision Nutrition Strategy at a Group Level in the Elderly N/A
Recruiting NCT05543980 - Leg Heat Therapy in Elderly Individuals Phase 2
Completed NCT04894929 - Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement N/A
Not yet recruiting NCT06071130 - Emotion, Aging, and Decision Making N/A
Enrolling by invitation NCT04641663 - Multi-target Dietary Supplement Tolerability in an Aging Population (MTDSST) N/A
Completed NCT04088006 - The Evaluation of Efficacy and Safety of Hyaluronic Acid Injection on Skin Moisturization and Elasticity N/A
Completed NCT03695081 - Patient Pathway Pharmacist - Optimal Drug-related Care N/A
Recruiting NCT05424263 - Acetate and Age-associated Arterial Dysfunction Phase 2
Completed NCT05601713 - Mitigating Heat-induced Physiological Strain and Discomfort in Older Adults Via Lower Limb Immersion and Neck Cooling N/A
Completed NCT04551339 - Zinc Versus Multivitamin Micronutrient Supplementation in the Setting of COVID-19 N/A
Recruiting NCT04997577 - Speech Perception and High Cognitive Demand N/A
Completed NCT05922475 - Efficacy of Pre-sleep or Post-exercise Protein During 12 Weeks of Resistance Exercise Training N/A
Completed NCT04015479 - Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Older Adults N/A