An observational study in Genetic Predisposition to Disease and Genetics Disease, sponsored by Helix, Inc. Recruiting at 14 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-23.
Sponsored by Helix, Inc · Observational
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.
235 studies on the registry are indexed under Genetic Predisposition to Disease; 94 are open to participants now.
This study's planned enrollment of 2,000,000 is above the median of 400 across 154 observational studies indexed under Genetic Predisposition to Disease.
Browse Genetic Predisposition to Disease studies →This is the only study on the registry with Helix, Inc as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Exome sequencing will be completed on each sample submitted.
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.
Time frame: 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.
Time frame: Through study completion, average 10 years
Re-Contact participants
Recontact participants for additional data collection, research participation opportunities, and return of results
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, average 10 years
Plan to share: Yes — 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.
Supporting information: Icf, Csr
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Genetic Predisposition to Disease→