Helix Research Network

Last updated: March 10, 2025
Sponsor: Helix, Inc
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Exome sequencing

Clinical Study ID

NCT06057181
HRN 001
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The Helix Research Network ("HRN") is a network of academic, public, and/or private healthcare organizations that are committed to advancing medical research and improving human health through large-scale genomics research and acceleration of the integration of genomic and other omics data into clinical care.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years and older

  • Willing and able to comply with all aspects of the protocol

Exclusion

Exclusion Criteria:

  • History of allogenic bone marrow transplant

  • History of allogenic stem cell transplant

  • Anything that would place the individual at increased risk or preclude anindividual's: 1) full compliance with study requirements; or 2) completion of thestudy based on the assessment from local consenting and enrolling Investigators.

Study Design

Total Participants: 2000000
Treatment Group(s): 1
Primary Treatment: Exome sequencing
Phase:
Study Start date:
September 13, 2021
Estimated Completion Date:
September 13, 2036

Study Description

The network will create a large-scale clinicogenomics dataset, which will support research to discover molecular and genetic determinants of disease risk, disease progression, treatment response, health economic outcomes, social or behavioral determinants of health, targets for therapeutic intervention, risk stratification, clinical implementation, and other clinical indicators of interest. This clinicogenomics dataset will be used to reveal molecular and/or genetic factors that could improve the diagnosis or medical treatment of individual participants and includes a process to share individual results with participants. Participants will also receive annual reports on study outcomes and the impact of HRN, as such information becomes available.

Institutional membership in HRN will consist of Helix and member healthcare systems (herein referred to as "HRN Member Site(s)"). The Helix Research Network is a multi-center research program that will enroll an unlimited number of participants. Participants will be recruited concurrently from HRN Member Sites. In some cases, HRN Member Sites may recruit participants from multiple clinical sites. Participants who meet the enrollment criteria established in this protocol will be enrolled if they or their legally authorized representative(s) provide informed consent in accordance with all applicable regulations and sIRB requirements. Participants will be enrolled until withdrawal from the study or end of the study. Participants may be recruited at any point during the study period, until the recruitment goals established by the protocol are met.

Connect with a study center

  • HealthPartners (myGenetics)

    Bloomington, Minnesota 55425
    United States

    Active - Recruiting

  • Nebraska Medicine - University of Nebraska Medical Center (Genetic Insights Project)

    Omaha, Nebraska 68198
    United States

    Active - Recruiting

  • Cone Health (Gene Connect)

    Burlington, North Carolina 27401
    United States

    Active - Recruiting

  • WakeMed (PreciselyYou)

    Raleigh, North Carolina 27610
    United States

    Active - Recruiting

  • The Ohio State University (Genomic Health)

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • St. Luke's University Health Network (DNAanswers)

    Bethlehem, Pennsylvania 18015
    United States

    Active - Recruiting

  • WellSpan Health (The Gene Health Project)

    York, Pennsylvania 17403
    United States

    Active - Recruiting

  • Medical University of South Carolina (In Our DNA SC)

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Sanford Health (Imagine You)

    Sioux Falls, South Dakota 57105
    United States

    Active - Recruiting

  • Memorial Hermann Health System (genoME)

    Houston, Texas 77030
    United States

    Active - Recruiting

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