Helix Research Network

Study Overview
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Brief Summary
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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
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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.

Official Title
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Helix Research Network

Conditions
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Genetic Predisposition to Disease, Genetics Disease

Intervention / Treatment
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* Genetic: Exome sequencing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: Exome sequencing|Exome sequencing will be completed on each sample submitted.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | Through study completion, average 10 years |