Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06057181
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2023-08-18
Brief Title:
Helix Research Network
Sponsor:
Helix Inc
Organization:
Helix Inc
Study Overview
Official Title:
Helix Research Network
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HRN
Brief Summary:
The Helix Research Network HRN is a network of academic public andor 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:
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 andor 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 Sites 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 representatives 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
Institutional membership in HRN will consist of Helix and member healthcare systems herein referred to as HRN Member Sites 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 representatives 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None