Helix Research Network

Genetic Predisposition to Disease Clinical Trial

— HRN  

Official title:

Helix Research Network

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06057181
• Other study ID #: HRN 001
• Status: Recruiting
• Start date: September 13, 2021
• Est. completion date: September 13, 2036

Study information

• Verified date: May 2024
• Source: Helix, Inc
• Contact: Catherine Clinton
• Phone: 844-211-2070
• Email: researchadmin[@]helix.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000000
• Est. completion date: September 13, 2036
• Est. primary completion date: September 13, 2031
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Genetic Predisposition to Disease
• Genetics Disease

Intervention

Genetic:
• Exome sequencing
Exome sequencing will be completed on each sample submitted.

Locations

Country	Name	City	State
United States	St. Luke's University Health Network (DNAanswers)	Bethlehem	Pennsylvania
United States	HealthPartners (myGenetics)	Bloomington	Minnesota
United States	Cone Health (Gene Connect)	Burlington	North Carolina
United States	Medical University of South Carolina (In Our DNA SC)	Charleston	South Carolina
United States	Memorial Hermann Health System (genoME)	Houston	Texas
United States	Nebraska Medicine - University of Nebraska Medical Center (Genetic Insights Project)	Omaha	Nebraska
United States	Sanford Health (Imagine You)	Sioux Falls	South Dakota
United States	WellSpan Health (The Gene Health Project)	York	Pennsylvania

Sponsors (7)

Lead Sponsor	Collaborator
Helix, Inc	HealthPartners Institute, Medical University of South Carolina, Memorial Hermann Health System, Nebraska Medicine - University of Nebraska Medical Center, St. Luke's Hospital and Health Network, Pennsylvania, WellSpan Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Re-Contact participants	Recontact participants for additional data collection, research participation opportunities, and return of results	Through study completion, average 10 years
Primary	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
Primary	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
Primary	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