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NCT06057181RecruitingAccepts Healthy Volunteers

Helix Research Network

Helix, Inc

Start Date

9/13/2021

Completion Date

9/13/2036

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.

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

GENETIC

Exome sequencing

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Conditions

Genetic Predisposition to DiseaseGenetics Disease

Locations

Parkview Health (DNA Insights)

Fort Wayne, Indiana 46845

United States

HealthPartners (myGenetics)

Bloomington, Minnesota 55425

United States

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

Omaha, Nebraska 68198

United States

Renown Health (Healthy Nevada Project)

Reno, Nevada 89502

United States

Rochester Regional Health (GenoWell)

Rochester, New York 14621

United States

Cone Health (Gene Connect)

Burlington, North Carolina 27401

United States

WakeMed (PreciselyYou)

Raleigh, North Carolina 27610

United States

TriHealth (DNA Discovery)

Cincinnati, Ohio 45202

United States

The Ohio State University (Genomic Health)

Columbus, Ohio 43210

United States

St. Luke's University Health Network (DNAanswers)

Bethlehem, Pennsylvania 18015

United States

WellSpan Health (The Gene Health Project)

York, Pennsylvania 17403

United States

Medical University of South Carolina (In Our DNA SC)

Charleston, South Carolina 29425

United States

Sanford Health (Imagine You)

Sioux Falls, South Dakota 57105

United States

Memorial Hermann Health System (genoME)

Houston, Texas 77030

United States