Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) Precision Medicine Phase 2 Option 1

Last updated on July 2021

Recruitment

Recruitment Status: Enrolling by invitation
Estimated Enrollment: Same as current

Summary

Conditions: Traumatic Brain Injury
Type: Observational
Design: Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age: Between 18 years and 65 years
Gender: Both males and females

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 world's 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, e.g., 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 i.e., 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.

Tracking Information

NCT #: NCT04602806
Collaborators: U.S. Army Medical Research and Development Command
Investigators: Study Director: Geoffrey T Manley, MD, PhD University of California, San Francisco Study Director: Claudia S Robertson, MD Baylor College of Medicine Study Director: David O Okonkwo, MD, PhD University of Pittsburgh Medical Center Study Director: Ramon Diaz-Arrastia, MD, PhD University of Pennsylvania Study Director: Nancy R Temkin, PhD University of Washington Study Director: Pratik Mukherjee, MD, PhD University of California, San Francisco Study Director: Joseph T Giacino, PhD Harvard Medical School, Spaulding Rehabilitation Hospital Study Director: Murray B Stein, MD, MPH University of California, San Diego Principal Investigator: Mike McCrea, PhD, ABPP Medical College of Wisconsin Principal Investigator: Ramesh Grandhi, MD, MS University of Utah