Project Baseline Health Study

Sponsor

Baseline Study LLC (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03154346

Collaborator

Verily Life Sciences LLC (Industry), Duke University (Other), Stanford University (Other), Google LLC. (Industry)

10,000

Enrollment

Locations

80.1

Anticipated Duration (Months)

2000

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
All

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

10000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Project Baseline Health Study

Actual Study Start Date :

Mar 29, 2017

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baseline Study	Mountain View	California	United States	94043
2	Stanford Medicine	Stanford	California	United States	94305
3	California Health and Longevity Institute	Westlake Village	California	United States	91362
4	Duke University School of Medicine	Durham	North Carolina	United States	27705
5	Duke University School of Medicine	Kannapolis	North Carolina	United States	28081