Helix Research Network

NCT ID: NCT06057181

Last Updated: 2026-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-13

Study Completion Date

2036-09-13

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Genetic Predisposition to Disease Genetics Disease

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

OTHER

Interventions

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Exome sequencing

Exome sequencing will be completed on each sample submitted.

Intervention Type GENETIC

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of South Carolina

OTHER

Sponsor Role collaborator

HealthPartners Institute

OTHER

Sponsor Role collaborator

Memorial Hermann Health System

OTHER

Sponsor Role collaborator

WellSpan Health

OTHER

Sponsor Role collaborator

St. Luke's Hospital and Health Network, Pennsylvania

OTHER

Sponsor Role collaborator

Sanford Health

OTHER

Sponsor Role collaborator

Renown Health

OTHER

Sponsor Role collaborator

WakeMed Health and Hospitals

OTHER

Sponsor Role collaborator

University of Nebraska

OTHER

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role collaborator

Cone Health

OTHER

Sponsor Role collaborator

Parkview Health

OTHER

Sponsor Role collaborator

Rochester Regional Health

UNKNOWN

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role collaborator

Helix, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William Lee, PhD

Role: PRINCIPAL_INVESTIGATOR

Helix, Inc

Locations

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Parkview Health

Fort Wayne, Indiana, United States

Site Status RECRUITING

HealthPartners (myGenetics)

Bloomington, Minnesota, United States

Site Status RECRUITING

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

Omaha, Nebraska, United States

Site Status RECRUITING

Rochester Regional Health

Rochester, New York, United States

Site Status RECRUITING

Cone Health (Gene Connect)

Burlington, North Carolina, United States

Site Status RECRUITING

WakeMed (PreciselyYou)

Raleigh, North Carolina, United States

Site Status RECRUITING

TriHealth

Cincinnati, Ohio, United States

Site Status RECRUITING

The Ohio State University (Genomic Health)

Columbus, Ohio, United States

Site Status RECRUITING

St. Luke's University Health Network (DNAanswers)

Bethlehem, Pennsylvania, United States

Site Status RECRUITING

WellSpan Health (The Gene Health Project)

York, Pennsylvania, United States

Site Status RECRUITING

Medical University of South Carolina (In Our DNA SC)

Charleston, South Carolina, United States

Site Status RECRUITING

Sanford Health (Imagine You)

Sioux Falls, South Dakota, United States

Site Status RECRUITING

Memorial Hermann Health System (genoME)

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Layla Anderson

Role: CONTACT

206-295-8866

Facility Contacts

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Jamie Renbarger, MD, MS

Role: primary

260-266-9950

Douglas Olson, MD

Role: primary

952-967-5357

Serena Gaines

Role: primary

402-559-1350

Heather R Bacchetta

Role: primary

(585) 922-4366

Alison Sigmon, PhD

Role: primary

336.890.2999

Casey Granack

Role: primary

Courtney Rice

Role: primary

(513) 862-9954

Hannah Beasley

Role: primary

614-366-GENE (4363)

Jean Reinert

Role: primary

484-658-6300

Rebecca Eberly, BSN

Role: primary

717-356-5395

Samantha Norman, MPH

Role: primary

843-876-0582

Grace Beuch

Role: primary

(888) 424-2332

Misty Ottman, BSN

Role: primary

713-704-5610

Other Identifiers

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HRN 001

Identifier Type: -

Identifier Source: org_study_id

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