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AllNCT03154346

Project Baseline Health Study

An observational study of All, run by Baseline Study LLC at 5 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is the first initiative of Project Baseline, a broader effort designed to develop a well-defined reference, or "baseline," of good health as well as a rich data platform that may be used to better understand the transition from health to disease and identify additional risk factors for disease. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
All
How many people
10,000 participants
Where
5 sitesUnited States
Study dates
29 Mar 2017to Dec 2024
How long will I take part?
6 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The Project Baseline study population will be composed of adults across the health spectrum, including exceptionally healthy participants, participants at risk of disease, and participants with current disease.

Who may be able to join

  • Age ≥ 18
  • U.S. Resident
  • Able to speak and read English
  • Willing and able to comply with all aspects of the protocol

Who cannot join

  • Individuals working on Project Baseline, including the Baseline Study
  • Known severe allergy to nickel or metal jewelry

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Duke University School of Medicine

    Durham, North Carolina, 27705

  • Duke University School of Medicine

    Kannapolis, North Carolina, 28081

  • Baseline Study

    South San Francisco, California, 94080

  • Stanford Medicine

    Stanford, California, 94305

  • California Health and Longevity Institute

    Westlake Village, California, 91361

Other trials in United States

About this study

This study is the first initiative of Project Baseline, a broader effort designed to develop a well-defined reference, or "baseline," of good health as well as a rich data platform that may be used to better understand the transition from health to disease and identify additional risk factors for disease. Project Baseline endeavors to test and develop new tools and technologies to collect, organize, and activate health information.

Conditions
All
Keywords
Baseline, Project Baseline, Baseline Study, Project Baseline Study, Health Study, Baseline Health Study
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03154346
Study groupRoleWhat they receive
General PopulationAn unlimited number of participants will be accepted into a Baseline registry. From the Baseline registry, approximately 10,000 participants will be selected for the Baseline Study. Participant enrollment for the Baseline Study will be stratified by age, sex and risk factors and will aim to reflect the race and ethnicity distribution within the U.S.. The population includes a broad range of participants across the health spectrum, including exceptionally healthy participants, participants at risk of disease, and participants with current disease. The study population will be enriched for participants with an elevated risk of primary cardiovascular disease, lung cancer, and/or breast/ovarian cancers.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Develop a set of scalable and standardized tools for acquiring, organizing, and analyzing clinical, molecular, imaging, sensor, self-reported, behavioral, environmental, and other health-related measurements

    Measured: For the duration of the study

  2. Evaluate the use of sensor technologies for the collection of continuous, accurate health information

    Measured: For the duration of the study

  3. Create a dataset encompassing a wide spectrum of phenotypic measures for future exploratory analysis

    Measured: For the duration of the study

  4. Measure the phenotypic diversity observed among a participant population, defining a range of expected values for multiple types of data

    Measured: For the duration of the study

  5. Identify biomarkers of disease-related transitions, including those related to cardiovascular disease and cancer

    Measured: For the duration of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2017
  2. Study start29 Mar 2017
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10,000 participants (estimated)
Target duration
6 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03154346
Sponsor's protocol ID
2017-BL-001
Status last verified
Sep 2024
First submitted
19 Apr 2017
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: It is envisioned that the Baseline Study data will be available to qualified researchers for exploratory analysis in the future. Qualified external researchers may apply through applications reviewed by the Proposal Review and Publications Committee and Scientific Executive Committee.

Publications

  • Carroll MK, Faheem S, Bouteiller J, Hernandez A, Mahaffey KW, Mega JL, Pagidipati N, Schaack T, Shah SH, Shashidhar S, Swope S, Williams D, Plowman RS, Simard EP, Short SA, Sullivan SS. Retention and characteristics associated with remote questionnaire completion in a general population cohort study: the project baseline health study. Front Digit Health. 2025 Jun 24;7:1520132. doi: 10.3389/fdgth.2025.1520132. eCollection 2025.

    PubMed 40630050

  • Duran JM, Shrader P, Hong C, Haddad F, Santana EJ, Cauwenberghs N, Kouznetsova T, Salerno M, Bloomfield G, Koweek L, Hernandez A, Mahaffey KW, Shah SH, Douglas PS, Daubert MA; Project Baseline Health Study Group. Abnormal Exercise Electrocardiography With Normal Stress Echocardiography Is Associated With Subclinical Coronary Atherosclerosis. Circ Cardiovasc Imaging. 2025 Feb;18(2):e017380. doi: 10.1161/CIRCIMAGING.124.017380. Epub 2025 Jan 13.

    PubMed 39801490

  • Feng KY, Short SA, Saeb S, Carroll MK, Olivier CB, Simard EP, Swope S, Williams D, Eckstrand J, Pagidipati N, Shah SH, Hernandez AF, Mahaffey KW. Resting Heart Rate and Associations With Clinical Measures From the Project Baseline Health Study: Observational Study. J Med Internet Res. 2024 Dec 20;26:e60493. doi: 10.2196/60493.

    PubMed 39705694

  • Doroodgar Jorshery S, Chandra J, Walia AS, Stumiolo A, Corey K, Zekavat SM, Zinzuwadia AN, Patel K, Short S, Mega JL, Plowman RS, Pagidipati N, Sullivan SS, Mahaffey KW, Shah SH, Hernandez AF, Christiani D, Aerts HJWL, Weiss J, Lu MT, Raghu VK. Leveraging Deep Learning of Chest Radiograph Images to Identify Individuals at High Risk for Chronic Obstructive Pulmonary Disease. medRxiv [Preprint]. 2024 Nov 15:2024.11.14.24317055. doi: 10.1101/2024.11.14.24317055.

    PubMed 39606360

  • Taylor KA, Carroll MK, Short SA, Celestin BE, Gilbertson A, Olivier CB, Haddad F, Cauwenberghs N. Factors associated with lower quarter performance-based balance and strength tests: a cross-sectional analysis from the project baseline health study. Front Sports Act Living. 2024 Jul 15;6:1393332. doi: 10.3389/fspor.2024.1393332. eCollection 2024.

    PubMed 39081837

  • Kercheval JB, Narcisse DI, Nguyen M, Rao SV, Gutierrez JA, Leeper NJ, Maron DJ, Rodriguez F, Hernandez AF, Mahaffey KW, Shah SH, Swaminathan RV; Project Baseline Health Study Group. Characterization of peripheral artery disease and associations with traditional risk factors, mobility, and biomarkers in the project baseline health study. Am Heart J. 2024 Sep;275:183-190. doi: 10.1016/j.ahj.2024.06.010. Epub 2024 Jul 3.

    PubMed 38969081

  • Uchehara B, Coulter Kwee L, Regan J, Chatterjee R, Eckstrand J, Swope S, Gold G, Schaack T, Douglas P, Mettu P, Haddad F, Shore S, Hernandez A, Mahaffey KW, Pagidipati N, Shah SH; Project Baseline Health Study Group. Accelerated Epigenetic Aging Is Associated With Multiple Cardiometabolic, Hematologic, and Renal Abnormalities: A Project Baseline Health Substudy. Circ Genom Precis Med. 2023 Jun;16(3):216-223. doi: 10.1161/CIRCGEN.122.003772. Epub 2023 Apr 11.

    PubMed 37039013

  • Haddad F, Cauwenberghs N, Daubert MA, Kobayashi Y, Bloomfield GS, Fleischman D, Koweek L, Maron DJ, Rodriguez F, Liao YJ, Moneghetti K, Amsallem M, Mega J, Hernandez A, Califf R, Mahaffey KW, Shah SH, Kuznetsova T, Douglas PS; Project Baseline Health Study Investigators. Association of left ventricular diastolic function with coronary artery calcium score: A Project Baseline Health Study. J Cardiovasc Comput Tomogr. 2022 Nov-Dec;16(6):498-508. doi: 10.1016/j.jcct.2022.06.003. Epub 2022 Jul 5.

    PubMed 35872137

  • Chatterjee R, Kwee LC, Pagidipati N, Koweek LH, Mettu PS, Haddad F, Maron DJ, Rodriguez F, Mega JL, Hernandez A, Mahaffey K, Palaniappan L, Shah SH; Project Baseline Health Study. Multi-dimensional characterization of prediabetes in the Project Baseline Health Study. Cardiovasc Diabetol. 2022 Jul 18;21(1):134. doi: 10.1186/s12933-022-01565-x.

    PubMed 35850765

  • Califf RM, Wong C, Doraiswamy PM, Hong DS, Miller DP, Mega JL; Baseline Study Group. Biological and clinical correlates of the patient health questionnaire-9: exploratory cross-sectional analyses of the baseline health study. BMJ Open. 2022 Jan 4;12(1):e054741. doi: 10.1136/bmjopen-2021-054741.

    PubMed 34983769

Questions about this trial

What is this clinical trial studying?

An observational study of All, run by Baseline Study LLC at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Develop a set of scalable and standardized tools for acquiring, organizing, and analyzing clinical, molecular, imaging, sensor, self-reported, behavioral, environmental, and other health-related measurements (time frame: For the duration of the study). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03154346, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024; AzTrials last refreshed its copy on 26 Oct 2026.

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