Clinical trial NCT06057181: Helix Research Network
Official title: Helix Research Network
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Genetic Predisposition to Disease
Genetics Disease
Lead sponsor: Helix, Inc
Sponsor class: INDUSTRY
Collaborators: name: Medical University of South Carolina
name: HealthPartners Institute
name: Memorial Hermann Health System
name: WellSpan Health
name: St. Luke's Hospital and Health Network, Pennsylvania
name: Nebraska Medicine - University of Nebraska Medical Center
name: Sanford Health
name: Cone Health
name: Renown Health
name: WakeMed Health & Hospitals
name: Ohio State University
First posted: 2023-09-28
Enrollment: 2000000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: OTHER
Sampling method: NON_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.

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.

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: 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.

Primary outcomes:
measure: Establish a Research Network
timeFrame: Through study completion, average 10 years
measure: Aggregate data
timeFrame: Through study completion, average 10 years
measure: Re-Contact participants
timeFrame: Through study completion, average 10 years
measure: Genetic biomarker identification
timeFrame: Through study completion, average 10 years
measure: Exploration of genetic determinants of disease
timeFrame: Through study completion, average 10 years
measure: Collection and analysis of Patient Reported Outcomes
timeFrame: Through study completion, average 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: HealthPartners (myGenetics)
state: Minnesota
city: Omaha
country: United States
facility: Nebraska Medicine - University of Nebraska Medical Center (Genetic Insights Project)
state: Nebraska
city: Burlington
country: United States
facility: Cone Health (Gene Connect)
state: North Carolina
city: Raleigh
country: United States
facility: WakeMed (PreciselyYou)
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University (Genomic Health)
state: Ohio
city: Bethlehem
country: United States
facility: St. Luke's University Health Network (DNAanswers)
state: Pennsylvania
city: York
country: United States
facility: WellSpan Health (The Gene Health Project)
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina (In Our DNA SC)
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford Health (Imagine You)
state: South Dakota
city: Houston
country: United States
facility: Memorial Hermann Health System (genoME)
state: Texas
Study officials:
affiliation: Helix, Inc
name: William Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References: