NCT06057181

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000,000

participants targeted

Target at P75+ for all trials

Timeline
126mo left

Started Sep 2021

Longer than P75 for all trials

Geographic Reach
1 country

14 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Sep 2021Sep 2036

Study Start

First participant enrolled

September 13, 2021

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2031

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2036

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

10 years

First QC Date

August 18, 2023

Last Update Submit

March 19, 2026

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    Through study completion, average 10 years

  • Re-Contact participants

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

    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.

    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.

    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.

    Through study completion, average 10 years

Interventions

Exome sequencing will be completed on each sample submitted.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Parkview Health (DNA Insights)

Fort Wayne, Indiana, 46845, United States

RECRUITING

HealthPartners (myGenetics)

Bloomington, Minnesota, 55425, United States

RECRUITING

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

Omaha, Nebraska, 68198, United States

RECRUITING

Renown Health (Healthy Nevada Project)

Reno, Nevada, 89502, United States

RECRUITING

Rochester Regional Health (GenoWell)

Rochester, New York, 14621, United States

RECRUITING

Cone Health (Gene Connect)

Burlington, North Carolina, 27401, United States

RECRUITING

WakeMed (PreciselyYou)

Raleigh, North Carolina, 27610, United States

RECRUITING

TriHealth (DNA Discovery)

Cincinnati, Ohio, 45202, United States

RECRUITING

The Ohio State University (Genomic Health)

Columbus, Ohio, 43210, United States

RECRUITING

St. Luke's University Health Network (DNAanswers)

Bethlehem, Pennsylvania, 18015, United States

RECRUITING

WellSpan Health (The Gene Health Project)

York, Pennsylvania, 17403, United States

RECRUITING

Medical University of South Carolina (In Our DNA SC)

Charleston, South Carolina, 29425, United States

RECRUITING

Sanford Health (Imagine You)

Sioux Falls, South Dakota, 57105, United States

RECRUITING

Memorial Hermann Health System (genoME)

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Genetic Predisposition to DiseaseGenetic Diseases, Inborn

Interventions

Exome Sequencing

Condition Hierarchy (Ancestors)

Disease SusceptibilityDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Whole Genome SequencingSequence Analysis, DNASequence AnalysisGenetic TechniquesInvestigative Techniques

Study Officials

  • William Lee, PhD

    Helix, Inc

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2023

First Posted

September 28, 2023

Study Start

September 13, 2021

Primary Completion (Estimated)

September 13, 2031

Study Completion (Estimated)

September 13, 2036

Last Updated

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
ICF, CSR
Time Frame
Data will be available for the duration of the study.
Access Criteria
An application to the Helix Research Network or a Member Site for Member Site level data.

Locations