Helix Research Network (HRN)

Helix, Inc.

Status: Enrolling

Conditions: Genetics Disease; Genetic Predisposition to Disease

Treatments: Genetic: Exome sequencing

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06057181

HRN 001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.