Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06540105
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Leveraging Artificial Intelligence and Multi-Omics Data to Predict Opioid Addiction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Leveraging Artificial Intelligence and Multi-Omics Data to Predict Opioid Addiction
Status:
RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
The primary goal of this proposal is to validate a novel genomic and microbiome predictive model that may be used to assess a persons risk of developing opioid use disorder OUD The following will be tested 1 MODUS Measuring risk for Opioid use Disorder Using SNPs which is a genomic panel consisting of a set number of proven single nucleotide polymorphisms SNP that utilizes machine learning to determine an individuals risk and 2 MICROUD MICRObiome for Opioid Use Disorder which will be a novel microbiome prediction panel for OUD risk MODUS and MICROUD will be developed using existing public datasets with genomic and microbiome data eg All of Us Human Microbiome Project During development of these predictive models in parallel an external prospective validation cohort will be recruited consisting of subjects from the University of California San Diego Veteran Affairs of San Diego and Veteran Affairs of Palo Alto each site with separate IRB The hypothesis is that MODUS and MICROUD will have high predictive potential for identifying high risk patients for OUD
Detailed Description:
The primary goal of this proposal is to validate a novel genomic and microbiome predictive model that may be used to assess a persons risk of developing opioid use disorder OUD The following will be tested 1 MODUS Measuring risk for Opioid use Disorder Using SNPs which is a genomic panel consisting of a set number of proven single nucleotide polymorphisms SNP that utilizes machine learning to determine an individuals risk and 2 MICROUD MICRObiome for Opioid Use Disorder which will be a novel microbiome prediction panel for OUD risk MODUS and MICROUD will be developed using existing public datasets with genomic and microbiome data eg All of Us Human Microbiome Project During development of these predictive models in parallel an external prospective validation cohort will be recruited consisting of subjects from the University of California San Diego Veteran Affairs of San Diego and Veteran Affairs of Palo Alto each site with separate IRB The hypothesis is that MODUS and MICROUD will have high predictive potential for identifying high risk patients for OUD
Specific Aim 1 Validate a novel genomic predictive panel assay - termed MODUS - in a prospective observational study that aims to recruit 300 subjects 200 from UCSD and VA San Diego with a history of OUD This genomic panel will be developed separately but then validated on the study population Healthy control data will be used from a publicly-available de-identified genomic dataset All of Us Research Program
Specific Aim 2 Validate a novel microbiome predictive panel assay - termed MICROUD - in a prospective observational study that aims to recruit 300 subjects 200 from UCSD and VA San Diego with a history of OUD This microbiome panel will be developed separately but then validated on the study population Healthy control data will be used from a publicly-available de-identified microbiome dataset Human Microbiome Project
Specific Aim 1 Validate a novel genomic predictive panel assay - termed MODUS - in a prospective observational study that aims to recruit 300 subjects 200 from UCSD and VA San Diego with a history of OUD This genomic panel will be developed separately but then validated on the study population Healthy control data will be used from a publicly-available de-identified genomic dataset All of Us Research Program
Specific Aim 2 Validate a novel microbiome predictive panel assay - termed MICROUD - in a prospective observational study that aims to recruit 300 subjects 200 from UCSD and VA San Diego with a history of OUD This microbiome panel will be developed separately but then validated on the study population Healthy control data will be used from a publicly-available de-identified microbiome dataset Human Microbiome Project
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