Helix Research Network (HRN)

March 19, 2026 updated by: Helix, Inc
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

2000000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Recruiting
        • Parkview Health (DNA Insights)
        • Contact:
    • Minnesota
      • Bloomington, Minnesota, United States, 55425
        • Recruiting
        • HealthPartners (myGenetics)
        • Contact:
        • Principal Investigator:
          • Douglas Olson, MD
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • Nebraska Medicine - University of Nebraska Medical Center (Genetic Insights Project)
        • Contact:
        • Principal Investigator:
          • Douglas Stoller, MD, PhD
    • Nevada
      • Reno, Nevada, United States, 89502
        • Recruiting
        • Renown Health (Healthy Nevada Project)
        • Contact:
        • Principal Investigator:
          • Joseph Grzymski, MD
    • New York
      • Rochester, New York, United States, 14621
        • Recruiting
        • Rochester Regional Health (GenoWell)
        • Contact:
        • Principal Investigator:
          • Pradyumna Phatak, MD
    • North Carolina
      • Burlington, North Carolina, United States, 27401
        • Recruiting
        • Cone Health (Gene Connect)
        • Contact:
        • Principal Investigator:
          • Chad Haldeman-Englert, MD
      • Raleigh, North Carolina, United States, 27610
        • Recruiting
        • WakeMed (PreciselyYou)
        • Contact:
        • Principal Investigator:
          • William Legarde, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45202
        • Recruiting
        • TriHealth (DNA Discovery)
        • Principal Investigator:
          • James Maher, MD
        • Contact:
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University (Genomic Health)
        • Contact:
        • Principal Investigator:
          • Amy Sturm, MS
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Recruiting
        • St. Luke's University Health Network (DNAanswers)
        • Contact:
        • Principal Investigator:
          • Christopher Chapman, MD
      • York, Pennsylvania, United States, 17403
        • Recruiting
        • WellSpan Health (The Gene Health Project)
        • Contact:
        • Principal Investigator:
          • C.Anwar Chahal, MD,PhD
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina (In Our DNA SC)
        • Principal Investigator:
          • Daniel Judge, MD
        • Contact:
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Sanford Health (Imagine You)
        • Contact:
        • Principal Investigator:
          • Stephen Powell, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Memorial Hermann Health System (genoME)
        • Contact:
        • Principal Investigator:
          • James McCarthy, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study will recruit the general population from the surrounding areas of the HRN Member Sites. This may include patients within a health system of the Site or community members in the surrounding area of Sites.

Description

Inclusion Criteria:

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

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 an individual's: 1) full compliance with study requirements; or 2) completion of the study based on the assessment from local consenting and enrolling Investigators.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Establish a Research Network
Time Frame: Through study completion, average 10 years
Establish a research network to support the advancement of biomedical research, improve human health through genomics research, and accelerate integration of genomic and other omics data into clinical care.
Through study completion, average 10 years
Aggregate data
Time Frame: Through study completion, average 10 years
Aggregate molecular, genomic data, phenotypic and other health-related data in centralized and/or federated databases to be accessed by investigators for approved research purposes.
Through study completion, average 10 years
Re-Contact participants
Time Frame: Through study completion, average 10 years
Recontact participants for additional data collection, research participation opportunities, and return of results
Through study completion, average 10 years
Genetic biomarker identification
Time Frame: Through study completion, average 10 years
Identification and characterization of clinical, histological, molecular, and genetic biomarkers that are linked to disease, disease outcomes, or that might be used to improvise disease classification.
Through study completion, average 10 years
Exploration of genetic determinants of disease
Time Frame: Through study completion, average 10 years
Exploration of the molecular and genetic underpinnings and determinants of disease, including disease risk, disease progression, treatment response, health economic outcomes, social or behavioral determinants of health, targets for therapeutic intervention, risk stratification, and other clinical indicators of interest.
Through study completion, average 10 years
Collection and analysis of Patient Reported Outcomes
Time Frame: Through study completion, average 10 years
Collection and analysis of Patient Reported Outcomes (e.g. quality of life, physical function, symptom burden) associated with diseases that have a genetic or molecular etiology. Validation of disease-specific instruments to assess the impact of genetic screening.
Through study completion, average 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helix, Inc

Collaborators

Medical University of South Carolina
University Health Network, Toronto
Ohio State University
HealthPartners Institute
University of Nebraska
WellSpan Health
St. Luke's Hospital and Health Network, Pennsylvania
Sanford Health
WakeMed Health and Hospitals
Cone Health
Memorial Hermann Health System
Parkview Health
Rochester Regional Health
Renown Health

Investigators

  • Principal Investigator: William Lee, PhD, Helix, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2021

Primary Completion (Estimated)

September 13, 2031

Study Completion (Estimated)

September 13, 2036

Study Registration Dates

First Submitted

August 18, 2023

First Submitted That Met QC Criteria

September 25, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRN 001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

As a population health research network, the primary purpose of HRN is to help researchers and clinicians better understand how genetic information may be used to improve the health of individuals and communities. It is possible that participants may receive actionable health information as a result of analysis of their DNA information. This means that the participant's genetic results may be used by their healthcare providers to inform medical decisions. It is also possible that novel discoveries may be generated from the research that could positively impact a participant's healthcare in the future.

IPD Sharing Time Frame

Data will be available for the duration of the study.

IPD Sharing Access Criteria

An application to the Helix Research Network or a Member Site for Member Site level data.

IPD Sharing Supporting Information Type

  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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