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NCT Number: NCT06057181

Helix Research Network

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.

Recruiting

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Key information

Conditions

Genetic Predisposition to Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Disease Susceptibility Genetic Diseases, Inborn Genetics Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Parkview Health (DNA Insights), Fort Wayne, Indiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exome sequencing

Genetic

Exome sequencing will be completed on each sample submitted.

Primary outcomes

  1. 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.

  2. 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.

  3. Re-Contact participants

    Time frame: Through study completion, average 10 years

    Recontact participants for additional data collection, research participation opportunities, and return of results

  4. 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.

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Layla Anderson

CONTACT

[email protected]

206-295-8866

Sponsors and collaborators

Lead sponsor

Helix, Inc

Industry

Collaborators

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

Registry information

Acronym: HRN

Important dates

Study start
2021
Primary completion
2031
Study completion
2036
First posted
Sep 28, 2023
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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