Recruiting

Biomarker Test

Sponsor:

Hoffmann-La Roche

Code:

NCT07455136

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Blood sample collection

Study Details

Brief 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).

Conditions

Traumatic Brain Injury

Study ID

NCT07455136

Start date

Feb 9, 2026

Status verified date

Aug, 2026

Completion date

Nov 23, 2028

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 1: Participants with Suspected TBI

Cohort 2: Hospitalized Participants with TBI

Interventions

Blood sample collection

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

Primary outcome measure

  • 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 [ Time Frame: Up to 2 weeks post-injury ]
  • Glasgow Outcome Scale-Extended (GOSE)-TBI Scores at Specified Timepoints [ Time Frame: 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 [ Time Frame: Up to 2 weeks post-injury ]
  • Percentage of Hospitalized Participants with Secondary Events, Based on CT Scan Findings per the Standard of Care [ Time Frame: Up to 2 weeks post-injury ]
  • CLIN12.1: Sensitivity of First Panel of Biomarkers Compared with TBI Diagnosis [ Time Frame: From Day 1 to 2 weeks post-injury ]
  • CLIN12.1: Specificity of First Panel of Biomarkers Compared with TBI Diagnosis [ Time Frame: From Day 1 to 2 weeks post-injury ]
  • CLIN12.1: Sensitivity of First Panel of Biomarkers Compared with Neuroworsening Results [ Time Frame: From Day 1 to 2 weeks post-injury ]
  • CLIN12.1: Specificity of First Panel of Biomarkers Compared with Neuroworsening Results [ Time Frame: From Day 1 to 2 weeks post-injury ]
  • CLIN12.1: Sensitivity of First Panel of Biomarkers Compared with GOSE-TBI Scores [ Time Frame: Days 14, 28, and 90 ]
  • CLIN12.1: Specificity of First Panel of Biomarkers Compared with GOSE-TBI Scores [ Time Frame: Days 14, 28, and 90 ]
  • CLIN12.2: Sensitivity of a Biomarker Compared with the Development of Secondary Events in Hospitalized Participants with TBI [ Time Frame: Up to 2 weeks post-injury ]
  • CLIN12.2: Specificity of a Biomarker Compared with the Development of Secondary Events in Hospitalized Participants with TBI [ Time Frame: Up to 2 weeks post-injury ]

Central Contacts and Locations

Central contacts

Marian Martinez

+1-815-394-9084marian.martinez@external.roche.com

Locations

University of California San Francisco

Recruiting

San Francisco, California, United States, 94110

Atrium Health - Carolina Medical Center

Recruiting

Charlotte, North Carolina, United States, 28203

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45229

University of Pennsylvania Medical Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-08-21.