HRN: Helix Research Network
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- Establish a Research Network [Through study completion, average 10 years]
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.
- Aggregate data [Through study completion, average 10 years]
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.
- Re-Contact participants [Through study completion, average 10 years]
Recontact participants for additional data collection, research participation opportunities, and return of results
- Genetic biomarker identification [Through study completion, average 10 years]
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.
- Exploration of genetic determinants of disease [Through study completion, average 10 years]
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.
- Collection and analysis of Patient Reported Outcomes [Through study completion, average 10 years]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 years and older
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Willing and able to comply with all aspects of the protocol
Exclusion Criteria:
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History of allogenic bone marrow transplant
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History of allogenic stem cell transplant
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | HealthPartners (myGenetics) | Bloomington | Minnesota | United States | 55425 |
| 2 | WellSpan Health (The Gene Health Project) | York | Pennsylvania | United States | 17403 |
| 3 | Medical University of South Carolina (In Our DNA SC) | Charleston | South Carolina | United States | 29425 |
| 4 | Memorial Hermann Health System (genoME) | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Helix, Inc
Investigators
- Principal Investigator: William Lee, PhD, Helix, Inc
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HRN 001