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Clinical Trials in the USA / NCT07455136
Recruiting Observational

A Study to Develop a Blood-based Test for Aiding the Diagnosis/Prognosis of Traumatic Brain Injury in Adults and for Monitoring the Development of Secondary Events in Patients Diagnosed With Traumatic Brain Injury

NCT07455136 · tracked via the Priya Life Science USA tracker
Sponsor
Hoffmann-La Roche
Phase
Observational
Started
2026-02-09
Last updated
2026-10-19

Condition(s) studied

Traumatic Brain Injury

Investigational drug(s) / intervention(s)

Blood sample collection

Blood sample collection: Blood samples from each enrolled participant in CLIN12.1 and/or CLIN12.2 will be collected.

Study summary

The study is intended to cover two purposes: first, to develop a blood-based biomarker test for aiding the diagnosis of traumatic brain injury (TBI) in adult participants and for prognosis of outcome of TBI (CLIN12.1); and second, for monitoring the development of secondary events in adult participants diagnosed with TBI (CLIN12.2).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Presenting to the Emergency Department with a biomechanically plausible mechanism of non-penetrating traumatic brain injury (TBI; direct impact: blow to the head, head against object, object against head; acceleration/deceleration) * Acute brain CT completed for standard of care Further Inclusion Criteria (specific for CLIN12.2): * Admitted to the hospital with radiographic evidence of acute TBI * Admitted to the intensive care unit at risk for decline related to TBI Exclusion Criteria: * Prior neurosurgical intervention within the last 6 months * Major debilitating neurological disease (such as, but not limited to: stroke, CVA, mild cognitive impairment, Alzheimer's disease, Amyotrophic lateral sclerosis, Parkinson's disease, Huntington's disease, Frontotemporal dementia, tumor, epilepsy, unmanaged seizure disorder), impairing baseline awareness, cognition, or validity of outcomes assessments * Major debilitating baseline mental health disorders (such as but not limited to schizophrenia or bipolar disorder) that would interfere with follow-up and the validity of outcome assessments * Significant pre-existing conditions that would interfere with follow-up and outcome assessment (such as, but not limited to: chronic kidney disease, chronic cardiovascular comorbidities, alcohol or substance use disorder) * History of melanoma * Primary diagnosis of ischemic or hemorrhagic stroke * Any spinal Cord Injury (American Spinal Injury Association \[ASIA\] score of A-D) * Received chemotherapy or radiation currently or within the last year * Patients on psychiatric hold (e.g., 5150, 5250) * Current incarceration or in custody * Known inability to undergo an MRI * Currently receiving any interventional treatments as a part of an investigational study/trial (drug, device, behavioral, treatment) at the time of enrollment and/or during the course of this study * Low likelihood of follow-up (e.g. participant or family indicating low interest, residence in another state or country, homelessness or lack of reliable contacts) * Any condition that, in the opinion of the investigator, could interfere in the proper execution of the study procedures and/or in their future permanence in the study

Primary outcome measure(s)

  • Percentage of Participants According to Traumatic Brain Injury (TBI) Diagnosis (Positive or Negative), Assessed by an Adjudication Panel Based on Structural Imaging (CT and MRI) and Clinical Summaries — Up to 2 weeks post-injury
  • Glasgow Outcome Scale-Extended (GOSE)-TBI Scores at Specified Timepoints — Days 14, 28, and 90
  • Percentage of Participants According to Neuroworsening Result (Positive or Negative), Assessed by an Adjudication Panel Based on Clinical and Radiological Findings — Up to 2 weeks post-injury
  • Percentage of Hospitalized Participants with Secondary Events, Based on CT Scan Findings per the Standard of Care — Up to 2 weeks post-injury
  • CLIN12.1: Sensitivity of First Panel of Biomarkers Compared with TBI Diagnosis — From Day 1 to 2 weeks post-injury
  • CLIN12.1: Specificity of First Panel of Biomarkers Compared with TBI Diagnosis — From Day 1 to 2 weeks post-injury
  • CLIN12.1: Sensitivity of First Panel of Biomarkers Compared with Neuroworsening Results — From Day 1 to 2 weeks post-injury
  • CLIN12.1: Specificity of First Panel of Biomarkers Compared with Neuroworsening Results — From Day 1 to 2 weeks post-injury
  • CLIN12.1: Sensitivity of First Panel of Biomarkers Compared with GOSE-TBI Scores — Days 14, 28, and 90
  • CLIN12.1: Specificity of First Panel of Biomarkers Compared with GOSE-TBI Scores — Days 14, 28, and 90
  • CLIN12.2: Sensitivity of a Biomarker Compared with the Development of Secondary Events in Hospitalized Participants with TBI — Up to 2 weeks post-injury
  • CLIN12.2: Specificity of a Biomarker Compared with the Development of Secondary Events in Hospitalized Participants with TBI — Up to 2 weeks post-injury

Trial sites (14)

FacilityCityRegionStatus
University Of California Davis, Neurological Surgery Sacramento California Recruiting
University of California San Francisco San Francisco California Recruiting
Goodman Campbell Brain and Spine/Ascension Carmel Indiana Not Yet Recruiting
Northwell Health - Department Of Neurosurgery Manhasset New York Not Yet Recruiting
Atrium Health - Carolina Medical Center Charlotte North Carolina Recruiting
University of Cincinnati Cincinnati Ohio Recruiting
University of Pennsylvania Medical Center Philadelphia Pennsylvania Recruiting
University of Pittsburgh Medical Center Pittsburgh Pennsylvania Recruiting
Brown University Providence Rhode Island Not Yet Recruiting
Vanderbilt University Medical Center Nashville Tennessee Not Yet Recruiting
Baylor College of Medicine Houston Texas Not Yet Recruiting
University of Utah Salt Lake City Utah Not Yet Recruiting
University of Wisconsin Madison Wisconsin Withdrawn
Medical College of Wisconsin Milwaukee Wisconsin Not Yet Recruiting

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Other trials for the same condition

Phase I Human Analytics (HALO) Study Recruiting
Traumatic Brain Injury and Stroke Long Term Outcome Recruiting
A Study to Evaluate the SENSE Device's Ability to Detect TBI Recruiting
An Observational Exploration of Clinical Trials Targeting Traumatic Brain Injury Starting soon
Autologous Adipose-Derived Mesenchymal Stem Cells for Chronic Traumatic Brain Injury Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07455136 on ClinicalTrials.gov ↗ ← All trials in the USA