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The Baseline Study

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ClinicalTrials.gov Identifier: NCT03154346
Recruitment Status : Recruiting
First Posted : May 16, 2017
Last Update Posted : July 28, 2017
Sponsor:
Collaborators:
Verily Life Sciences LLC
Duke University
Stanford University
Google Inc.
Information provided by (Responsible Party):
Baseline Study LLC

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
All

Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Years
Official Title: The Baseline Study
Actual Study Start Date : March 29, 2017
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Group/Cohort
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.



Primary Outcome Measures :
  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 [ Time Frame: For the duration of the study ]
  2. Evaluate the use of sensor technologies for the collection of continuous, accurate health information [ Time Frame: For the duration of the study ]
  3. Create a dataset encompassing a wide spectrum of phenotypic measures for future exploratory analysis [ Time Frame: 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 [ Time Frame: For the duration of the study ]
  5. Identify biomarkers of disease-related transitions, including those related to cardiovascular disease and cancer [ Time Frame: For the duration of the study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability 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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03154346


Contacts
Contact: Baseline Call Center 1-855-522-7354 contact@projectbaseline.com

Locations
United States, California
Baseline Study Recruiting
Mountain View, California, United States, 94043
Stanford Medicine Recruiting
Stanford, California, United States, 94305
California Health and Longevity Institute Recruiting
Westlake Village, California, United States, 91362
United States, North Carolina
Duke University School of Medicine Recruiting
Durham, North Carolina, United States, 27705
Duke University School of Medicine Recruiting
Kannapolis, North Carolina, United States, 28081
Sponsors and Collaborators
Baseline Study LLC
Verily Life Sciences LLC
Duke University
Stanford University
Google Inc.

Responsible Party: Baseline Study LLC
ClinicalTrials.gov Identifier: NCT03154346     History of Changes
Other Study ID Numbers: 2017-BL-001
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Baseline Study LLC:
Baseline
Project Baseline
Baseline Study
Project Baseline Study