Genetic Predisposition to DiseaseHRNNCT06057181
Helix Research Network
An observational study of Genetic Predisposition to Disease and Genetics Disease, run by Helix, Inc at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Genetic Predisposition to Disease, Genetics Disease
- What is being tested?
- Exome sequencing
- How many people
- 2,000,000 participants
- Where
- 14 sitesUnited States
- Study dates
- 13 Sep 2021to 13 Sep 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 18 years and older
- Willing and able to comply with all aspects of the protocol
Who cannot join
- 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.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites, 14 recruiting
- Recruiting
St. Luke's University Health Network (DNAanswers)
Bethlehem, Pennsylvania, 18015
Jean Reinert, 484-658-6300, DNAanswers@sluhn.org
Christopher Chapman, MD
- Recruiting
HealthPartners (myGenetics)
Bloomington, Minnesota, 55425
Douglas Olson, MD, 952-967-5357, mygenetics@healthpartners.com
Douglas Olson, MD
- Recruiting
Cone Health (Gene Connect)
Burlington, North Carolina, 27401
Alison Sigmon, PhD, 336.890.2999, geneconnect@conehealth.com
Chad Haldeman-Englert, MD
- Recruiting
Medical University of South Carolina (In Our DNA SC)
Charleston, South Carolina, 29425
Samantha Norman, MPH, 843-876-0582, inourdnasc@musc.edu
Daniel Judge, MD
- Recruiting
TriHealth (DNA Discovery)
Cincinnati, Ohio, 45202
Courtney Rice, (513) 862-9954, DNADiscovery@TriHealth.com
James Maher, MD
- Recruiting
The Ohio State University (Genomic Health)
Columbus, Ohio, 43210
Hannah Beasley, 614-366-GENE (4363), genomichealth@osumc.edu
Amy Sturm, MS
- Recruiting
Parkview Health (DNA Insights)
Fort Wayne, Indiana, 46845
Jamie Renbarger, MD, MS, 260-266-9950, DNAInsights@parkview.com
- Recruiting
Memorial Hermann Health System (genoME)
Houston, Texas, 77030
Misty Ottman, BSN, 713-704-5610, Misty.Ottman@memorialhermann.org
James McCarthy, MD
- Recruiting
Nebraska Medicine - University of Nebraska Medical Center (Genetic Insights Project)
Omaha, Nebraska, 68198
Serena Gaines, 402-559-1350, Geneticinsights@NebraskaMed.com
Douglas Stoller, MD, PhD
- Recruiting
WakeMed (PreciselyYou)
Raleigh, North Carolina, 27610
Casey Granack, preciselyyou@wakemed.org
William Legarde, MD
- Recruiting
Renown Health (Healthy Nevada Project)
Reno, Nevada, 89502
Savanna Grime, MPH, 775-982-7995, savanna.grime@renown.org
Joseph Grzymski, MD
- Recruiting
Rochester Regional Health (GenoWell)
Rochester, New York, 14621
Heather R Bacchetta, (585) 922-4366, GenoWell@rochesterregional.org
Pradyumna Phatak, MD
- Recruiting
Sanford Health (Imagine You)
Sioux Falls, South Dakota, 57105
Grace Beuch, (888) 424-2332, imageneticsinfo@sanfordhealth.org
Stephen Powell, MD
- Recruiting
WellSpan Health (The Gene Health Project)
York, Pennsylvania, 17403
Rebecca Eberly, BSN, 717-356-5395, reberly2@wellspan.org
C.Anwar Chahal, MD,PhD
About this study
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.
Read the 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.
- Being tested
- Exome sequencing
- Medical subject headings
- Genetic Predisposition to Disease, Genetic Diseases, Inborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exome sequencingGenetic
Exome sequencing will be completed on each sample submitted.
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish a Research Network
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.
Measured: Through study completion, average 10 years
Aggregate data
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.
Measured: Through study completion, average 10 years
Re-Contact participants
Recontact participants for additional data collection, research participation opportunities, and return of results
Measured: Through study completion, average 10 years
Genetic biomarker identification
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.
Measured: Through study completion, average 10 years
Exploration of genetic determinants of disease
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.
Measured: Through study completion, average 10 years
Collection and analysis of Patient Reported Outcomes
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.
Measured: Through study completion, average 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start13 Sep 2021
- Primary completion13 Sep 2031 (estimated)
- Study completion13 Sep 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic Predisposition to DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Other
- Enrolment
- 2,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helix, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical University of South Carolina, HealthPartners Institute, Memorial Hermann Health System, WellSpan Health, St. Luke's Hospital and Health Network, Pennsylvania, Sanford Health, Renown Health, WakeMed Health and Hospitals, University of Nebraska, Ohio State University, Cone Health, Parkview Health, Rochester Regional Health, University Health Network, Toronto
- Responsible party
- Sponsor
- Investigators
- William Lee, PhD, Principal investigator, Helix, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057181
- Sponsor's protocol ID
- HRN 001
- Acronym
- HRN
- Status last verified
- Mar 2026
- First submitted
- 18 Aug 2023
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helix Research Network
- ClinicalTrials.gov ID
- NCT06057181
- Acronym / sponsor ID
- HRN / HRN 001
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000,000 participants (estimated)
- Lead sponsor
- Helix, IncIndustry (pharma, biotech, devices)
- Collaborators
- Medical University of South Carolina, HealthPartners Institute, Memorial Hermann Health System, WellSpan Health, St. Luke's Hospital and Health Network, Pennsylvania, Sanford Health, Renown Health, WakeMed Health and Hospitals, University of Nebraska, Ohio State University, Cone Health, Parkview Health, Rochester Regional Health, University Health Network, Toronto
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 13 Sep 2031 (estimated)
- Study completion
- 13 Sep 2036 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Ecologic or community
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 18 years and older
- Willing and able to comply with all aspects of the protocol
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exome sequencingExome sequencing will be completed on each sample submitted. | Genetic | – |
Primary outcome
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.
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.
Re-Contact participants
Time frame: Through study completion, average 10 years
Recontact participants for additional data collection, research participation opportunities, and return of results
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William Lee, PhD principal investigator
Helix, Inc
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genetic Predisposition to Disease and Genetics Disease, run by Helix, Inc at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Layla Anderson (206-295-8866, researchadmin@helix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish a Research Network (time frame: Through study completion, average 10 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.