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

A Multicenter Prospective Study to Develop a Blood-based Biomarker Test for Aiding the Diagnosis/Prognosis of Traumatic Brain Injury in Adult Subjects (CLIN12.1) and for Monitoring the Development of Secondary Events in Patients Diagnosed With Traumatic Brain Injury (CLIN12.2)

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).

Study Overview

• Status: Recruiting
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Procedure: Blood sample collection

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Marian Martinez; Phone Number: +1-815-394-9084; Email: marian.martinez@external.roche.com

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • Not yet recruiting
      • University Of California Davis, Neurological Surgery
    • San Francisco, California, United States, 94110
      • Recruiting
      • University of California San Francisco
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Not yet recruiting
      • Goodman Campbell Brain and Spine/Ascension
  • New York
    • Manhasset, New York, United States, 11030
      • Not yet recruiting
      • Northwell Health - Department Of Neurosurgery
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Recruiting
      • Atrium Health - Carolina Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Not yet recruiting
      • University of Cincinnati
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Not yet recruiting
      • University of Pennsylvania Medical Center
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburgh Medical Center
  • Rhode Island
    • Providence, Rhode Island, United States, 29903
      • Not yet recruiting
      • Brown University
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Not yet recruiting
      • Vanderbilt University Medical Center
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Not yet recruiting
      • University of Utah
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Withdrawn
      • University of Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Not yet recruiting
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Participants who present at the emergency department with suspected TBI as per the eligibility criteria from approximately 10 to 15 sites in geographically diverse locations within the United States.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1: Participants with Suspected TBI	Procedure: Blood sample collection; Blood samples from each enrolled participant in CLIN12.1 and/or CLIN12.2 will be collected.
Cohort 2: Hospitalized Participants with TBI	Procedure: Blood sample collection; Blood samples from each enrolled participant in CLIN12.1 and/or CLIN12.2 will be collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
CLIN12.1: Sensitivity of Second Panel of Biomarkers Compared with TBI Diagnosis	From Day 1 to 2 weeks post-injury
CLIN12.1: Specificity of Second Panel of Biomarkers Compared with TBI Diagnosis	From Day 1 to 2 weeks post-injury
CLIN12.1: Sensitivity of Second Panel of Biomarkers Compared with Neuroworsening Results	From Day 1 to 2 weeks post-injury
CLIN12.1: Specificity of Second Panel of Biomarkers Compared with Neuroworsening Results	From Day 1 to 2 weeks post-injury
CLIN12.1: Sensitivity of Second Panel of Biomarkers Compared with GOSE-TBI Scores	Days 14, 28, and 90
CLIN12.1: Specificity of Second Panel of Biomarkers Compared with GOSE-TBI Scores	Days 14, 28, and 90
CLIN12.2: Sensitivity of a Second Biomarker Compared with the Development of Secondary Events in Hospitalized Participants with TBI	Up to 2 weeks post-injury
CLIN12.2: Specificity of a Second Biomarker Compared with the Development of Secondary Events in Hospitalized Participants with TBI	Up to 2 weeks post-injury

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: Roche Diagnostics GmbH
• Investigators: Study Director: Clinical Trials, Roche Diagnostics Gmbh

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: March 3, 2026
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: RD007282

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO