Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06641726
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Creating a Global Research Database That Connects Genetic Information and Long-term Health Data to Improve Personalized Treatment for People with Serious Mental Illness
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Developing an Internationally-diverse Linked Genomic and Longitudinal Phenotypic Research Dataset to Accelerate Precision Psychiatry for Patients with Serious Mental Illness
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GlobalMinds
Brief Summary:
This observational study aims to provide new insights into the nature and classification of severe mental illness and dementias that in time should help improve diagnostic practise and enable the development of new and improved treatments The investigators will achieve aims by gathering information and biological samples from over 50000 research participants and then linking this information with participants electronic health records genetic and other potential markers of mental illnesses called biomarkers derived from biological samples The investigators will use this resource to analyse how potential risk factors - genetic other biological and non-biological related to the participants life circumstances - influence participants experiences symptoms and outcomes both mental and physical health The investigators will also use advanced analysis to assess whether there may be better ways of grouping together and understanding the experiences of those with severe mental illnesses and dementias Given the value and importance of this resource for advancing mental health research the investigators will also make the data available to other researchers to pursue these broad research aims
Detailed Description:
GlobalMinds is a research study with the goal of creating a precision psychiatry bioresource combining biological and clinical data on 50000 participants with severe mental illness and dementia The investigators will use this resource to investigate how genomics other biological measures and non-biological risk factors are associated with these conditions and their outcomes In addition the investigators will deploy advanced analytic approaches to explore whether the combined dataset can help us derive more precise classification and diagnostic approaches and better prediction of outcomes The investigators will also work with other researchers and enable access to the dataset to address these questions In doing so the investigators seek to enable the development of novel treatment options and improved biologically informed classification for the most challenging conditions in psychiatry and dementia
The GlobalMinds programme is a precision neuroscience initiative PNI Its purpose is to improve the quality and availability of genomic and health care data for research into severe neuropsychiatric and degenerative ilnesses The study will involve the whole genome sequencing from 50000 patients suffering from neuropsychiatric and neurodegenerative disorders and linking this data to their individual electronic health records EHRs available within the Akrivia Health platform
No investigational product will be used but the trial will deploy methods of clinical phenotyping genomic sequencing biobanking diverse recruitment strategies in order to allow researchers to identify translatable biomarkers and disease-modifying targets for drug development downstream
This research study will develop a recruitment infrastructure that embraces the advantages conferred by the NHS research ecosystem but crucially adds to existing NIHR and NHS strategies in order to meet our ambitious recruitment target In GlobalMinds a national multi-media participant engagement campaign delivered in partnership with the NHS will direct patients with capacity to a centralised digital portal - the GlobalMinds Hub - to automate a large proportion of study activity This process will be managed by a dedicated study team run by Akrivia Health The GlobalMinds study team will monitor recruitment rates and sample diversity provide quality assurance on participant-generated data coordinate the network of expert project partners responsible for the national engagement campaign PPI and digital infrastructure and crucially undertake local community outreach targeted recruitment and in-person sample collection to minimise the risk of digital exclusion For 40000 participants who will provide DNA for whole genome sequencing patients will be screened and recruited into the study remotely and issued a remote DNA capture pack that patients can use and return in their own time Where participants express an interest in doing so on-site and mobile phlebotomy services will be used to obtain bloods samples for participants electing to participate in the biomarker cohort
The investigators will use the Global Minds data resource to address broad research objectives but also work with and provide secure access to the data resource for the wider research community both academic and non-academic researchers in the UK and abroad Levels of access will be determined by Akrivias Data Access Committee upon request from a research team
The GlobalMinds programme is a precision neuroscience initiative PNI Its purpose is to improve the quality and availability of genomic and health care data for research into severe neuropsychiatric and degenerative ilnesses The study will involve the whole genome sequencing from 50000 patients suffering from neuropsychiatric and neurodegenerative disorders and linking this data to their individual electronic health records EHRs available within the Akrivia Health platform
No investigational product will be used but the trial will deploy methods of clinical phenotyping genomic sequencing biobanking diverse recruitment strategies in order to allow researchers to identify translatable biomarkers and disease-modifying targets for drug development downstream
This research study will develop a recruitment infrastructure that embraces the advantages conferred by the NHS research ecosystem but crucially adds to existing NIHR and NHS strategies in order to meet our ambitious recruitment target In GlobalMinds a national multi-media participant engagement campaign delivered in partnership with the NHS will direct patients with capacity to a centralised digital portal - the GlobalMinds Hub - to automate a large proportion of study activity This process will be managed by a dedicated study team run by Akrivia Health The GlobalMinds study team will monitor recruitment rates and sample diversity provide quality assurance on participant-generated data coordinate the network of expert project partners responsible for the national engagement campaign PPI and digital infrastructure and crucially undertake local community outreach targeted recruitment and in-person sample collection to minimise the risk of digital exclusion For 40000 participants who will provide DNA for whole genome sequencing patients will be screened and recruited into the study remotely and issued a remote DNA capture pack that patients can use and return in their own time Where participants express an interest in doing so on-site and mobile phlebotomy services will be used to obtain bloods samples for participants electing to participate in the biomarker cohort
The investigators will use the Global Minds data resource to address broad research objectives but also work with and provide secure access to the data resource for the wider research community both academic and non-academic researchers in the UK and abroad Levels of access will be determined by Akrivias Data Access Committee upon request from a research team
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None