NCT03154346

Brief 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. Project Baseline endeavors to test and develop new tools and technologies to collect, organize, and activate health information.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 29, 2017

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2017

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 16, 2017

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

7.7 years

First QC Date

April 19, 2017

Last Update Submit

September 4, 2024

Conditions

Keywords

BaselineProject BaselineBaseline StudyProject Baseline StudyHealth StudyBaseline Health Study

Outcome Measures

Primary Outcomes (5)

  • 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

    For the duration of the study

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

    For the duration of the study

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

    For the duration of the study

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

    For the duration of the study

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

    For the duration of the study

Study Arms (1)

General Population

An 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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Baseline Study

South San Francisco, California, 94080, United States

Location

Stanford Medicine

Stanford, California, 94305, United States

Location

California Health and Longevity Institute

Westlake Village, California, 91361, United States

Location

Duke University School of Medicine

Durham, North Carolina, 27705, United States

Location

Duke University School of Medicine

Kannapolis, North Carolina, 28081, United States

Location

Related Publications (10)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2017

First Posted

May 16, 2017

Study Start

March 29, 2017

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

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.

Locations