Ignite Creation Date:
2024-05-06 @ 3:22 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04602806
Status:
COMPLETED
Last Update Posted:
2023-03-15
First Post:
2020-10-20
Brief Title:
Transforming Research and Clinical Knowledge in Traumatic Brain Injury TRACK-TBI Precision Medicine Phase 2 Option 1
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
TRACK-TBI Precision Medicine Phase 2-Option I
Status:
COMPLETED
Status Verified Date:
2023-03
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:
None
Brief Summary:
This study is being conducted to validate early and ultra-early blood-based and novel imaging biomarkers of Diffuse Axonal Injury DAI Microvascular Injury MVI and neuroinflammation that may serve as predictive and pharmacodynamic biomarkers in a new cohort of moderate-severe TRACK-TBI subjects The study team will enroll a cohort of moderate to severe TBI subjects N50 stratified according to VADoD criteria for these injury severities through the existing TRACK-TBI network sites to obtain novel advanced neuroimaging and more frequent biomarker sampling Subjects will be assessed over 3 months
Detailed Description:
In 2009 the multicenter Transforming Research and Clinical Knowledge in Traumatic Brain Injury Consortium was implemented to characterize the clinical magnetic resonance imaging MRI and blood-based biomarker features of TBI to inform design of next-generation precision medicine clinical trials in TBI Over the past 10 years TRACK-TBI has been supported by National Institute of Neurological Disorders and Stroke NINDS Department of Defense DoD Department of Energy DoE the National Football League and other philanthropic and industry partners TRACK-TBI has enrolled 3000 control and TBI subjects across the injury spectrum at 18 US Level 1 Trauma Centers This effort has established the worlds largest collection of TBI imaging studies and bio-specimens The study results are already being adopted into clinical research and bedside practice The TRACK-TBI Consortium is now primed to deliver on critical military and public health knowledge gaps and needs objective classification of TBI based on what is termed as mechanistic endophenotypes eg diffuse axonal injury DAI microvascular injury MVI and neuroinflammation An endophenotype is an internal phenotype discoverable by biochemical physiological radiological pathological or other techniques which is intermediate between a complex phenotype and the presumptive genetic or environmental contribution to a disease Endophenotypes are quantitative continuous variables unlike a phenotype which is usually a binary categorical variable These mechanistic endophenotypes defined by imaging and blood-based biomarkers will direct targeted treatments based on mechanism providing the tools needed for successful execution of precision medicine clinical trials To achieve the goal of precision medicine in TBI it is necessary to identify subgroups of TBI patients that will respond to a targeted therapy Investigators will assess putative blood-based and neuroimaging biomarkers for DAI MVI and neuroinflammation Fluid biomarkers complement imaging markers and may provide important tools for precision medicine clinical trials Investigators will collect acute data early and ultra-early ie hours-days following injury to validate the utility of these biomarkers in defining TBI mechanistic endophenotypes for use in clinical trials
Specific Aim for TRACK-TBI Precision Medicine Phase 2-Option 1 To validate early and ultra-early blood based and novel imaging biomarkers of DAI MVI and neuroinflammation that may serve as predictive and pharmacodynamic biomarkers in a cohort of moderate-severe subjects
Specific Aim for TRACK-TBI Precision Medicine Phase 2-Option 1 To validate early and ultra-early blood based and novel imaging biomarkers of DAI MVI and neuroinflammation that may serve as predictive and pharmacodynamic biomarkers in a cohort of moderate-severe subjects
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