Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Medical University of South Carolina | OTHER |
| HealthPartners Institute | OTHER |
| Memorial Hermann Health System | OTHER |
| WellSpan Health |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exome sequencing | Genetic | Exome sequencing will be completed on each sample submitted. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Layla Anderson | Contact | 206-295-8866 | researchadmin@helix.com |
| Name | Affiliation | Role |
|---|---|---|
| William Lee, PhD | Helix, Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkview Health (DNA Insights) | Recruiting | Fort Wayne | Indiana | 46845 | United States |
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.
Data will be available for the duration of the study.
An application to the Helix Research Network or a Member Site for Member Site level data.
Not provided
Not provided
| ID | Term |
|---|---|
| D020022 | Genetic Predisposition to Disease |
| D030342 | Genetic Diseases, Inborn |
| ID | Term |
|---|---|
| D004198 | Disease Susceptibility |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000073359 | Exome Sequencing |
| ID | Term |
|---|---|
| D000073336 | Whole Genome Sequencing |
| D017422 | Sequence Analysis, DNA |
| D017421 | Sequence Analysis |
| D005821 | Genetic Techniques |
Not provided
Not provided
| OTHER |
| St. Luke's Hospital and Health Network, Pennsylvania | OTHER |
| Sanford Health | OTHER |
| Renown Health | OTHER |
| WakeMed Health and Hospitals | OTHER |
| University of Nebraska | OTHER |
| Ohio State University | OTHER |
| Cone Health | OTHER |
| Parkview Health | OTHER |
| Rochester Regional Health | UNKNOWN |
| University Health Network, Toronto | OTHER |
Not provided
Not provided
Not provided
| Through study completion, average 10 years |
| HealthPartners (myGenetics) | Recruiting | Bloomington | Minnesota | 55425 | United States |
|
| Nebraska Medicine - University of Nebraska Medical Center (Genetic Insights Project) | Recruiting | Omaha | Nebraska | 68198 | United States |
|
| Renown Health (Healthy Nevada Project) | Recruiting | Reno | Nevada | 89502 | United States |
|
| Rochester Regional Health (GenoWell) | Recruiting | Rochester | New York | 14621 | United States |
|
| Cone Health (Gene Connect) | Recruiting | Burlington | North Carolina | 27401 | United States |
|
| WakeMed (PreciselyYou) | Recruiting | Raleigh | North Carolina | 27610 | United States |
|
| TriHealth (DNA Discovery) | Recruiting | Cincinnati | Ohio | 45202 | United States |
|
| The Ohio State University (Genomic Health) | Recruiting | Columbus | Ohio | 43210 | United States |
|
| St. Luke's University Health Network (DNAanswers) | Recruiting | Bethlehem | Pennsylvania | 18015 | United States |
|
| WellSpan Health (The Gene Health Project) | Recruiting | York | Pennsylvania | 17403 | United States |
|
| Medical University of South Carolina (In Our DNA SC) | Recruiting | Charleston | South Carolina | 29425 | United States |
|
| Sanford Health (Imagine You) | Recruiting | Sioux Falls | South Dakota | 57105 | United States |
|
| Memorial Hermann Health System (genoME) | Recruiting | Houston | Texas | 77030 | United States |
|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008919 |
| Investigative Techniques |