Traumatic Brain InjuryNCT07455136
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
An observational study of Traumatic Brain Injury, run by Hoffmann-La Roche at 14 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Blood sample collection
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 14 sitesUnited States
- Study dates
- 9 Feb 2026to 23 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites, 13 recruiting
- Not yet recruiting
Goodman Campbell Brain and Spine/Ascension
Carmel, Indiana, 46032
- Recruiting
Atrium Health - Carolina Medical Center
Charlotte, North Carolina, 28203
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45229
- Not yet recruiting
Baylor College of Medicine
Houston, Texas, 77030
- Withdrawn
University of Wisconsin
Madison, Wisconsin, 53792
- Not yet recruiting
Northwell Health - Department Of Neurosurgery
Manhasset, New York, 11030
- Not yet recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
- Not yet recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
- Recruiting
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
- Not yet recruiting
Brown University
Providence, Rhode Island, 29903
- Recruiting
University Of California Davis, Neurological Surgery
Sacramento, California, 95817
- Not yet recruiting
University of Utah
Salt Lake City, Utah, 84132
- Recruiting
University of California San Francisco
San Francisco, California, 94110
About this study
Official title: 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).
- Conditions
- Traumatic Brain Injury
- Being tested
- Blood sample collection
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collectionProcedure or surgery
Blood samples from each enrolled participant in CLIN12.1 and/or CLIN12.2 will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Participants with Suspected TBI | Not described Receives: Procedure: Blood sample collection | |
| Cohort 2: Hospitalized Participants with TBI | Not described Receives: Procedure: Blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 2 weeks post-injury
Glasgow Outcome Scale-Extended (GOSE)-TBI Scores at Specified Timepoints
Measured: 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
Measured: Up to 2 weeks post-injury
Percentage of Hospitalized Participants with Secondary Events, Based on CT Scan Findings per the Standard of Care
Measured: Up to 2 weeks post-injury
CLIN12.1: Sensitivity of First Panel of Biomarkers Compared with TBI Diagnosis
Measured: From Day 1 to 2 weeks post-injury
CLIN12.1: Specificity of First Panel of Biomarkers Compared with TBI Diagnosis
Measured: From Day 1 to 2 weeks post-injury
CLIN12.1: Sensitivity of First Panel of Biomarkers Compared with Neuroworsening Results
Measured: From Day 1 to 2 weeks post-injury
CLIN12.1: Specificity of First Panel of Biomarkers Compared with Neuroworsening Results
Measured: From Day 1 to 2 weeks post-injury
CLIN12.1: Sensitivity of First Panel of Biomarkers Compared with GOSE-TBI Scores
Measured: Days 14, 28, and 90
CLIN12.1: Specificity of First Panel of Biomarkers Compared with GOSE-TBI Scores
Measured: Days 14, 28, and 90
CLIN12.2: Sensitivity of a Biomarker Compared with the Development of Secondary Events in Hospitalized Participants with TBI
Measured: Up to 2 weeks post-injury
CLIN12.2: Specificity of a Biomarker Compared with the Development of Secondary Events in Hospitalized Participants with TBI
Measured: Up to 2 weeks post-injury
Secondary outcomes (8)
CLIN12.1: Sensitivity of Second Panel of Biomarkers Compared with TBI Diagnosis
Measured: From Day 1 to 2 weeks post-injury
CLIN12.1: Specificity of Second Panel of Biomarkers Compared with TBI Diagnosis
Measured: From Day 1 to 2 weeks post-injury
CLIN12.1: Sensitivity of Second Panel of Biomarkers Compared with Neuroworsening Results
Measured: From Day 1 to 2 weeks post-injury
CLIN12.1: Specificity of Second Panel of Biomarkers Compared with Neuroworsening Results
Measured: From Day 1 to 2 weeks post-injury
CLIN12.1: Sensitivity of Second Panel of Biomarkers Compared with GOSE-TBI Scores
Measured: Days 14, 28, and 90
CLIN12.1: Specificity of Second Panel of Biomarkers Compared with GOSE-TBI Scores
Measured: Days 14, 28, and 90
CLIN12.2: Sensitivity of a Second Biomarker Compared with the Development of Secondary Events in Hospitalized Participants with TBI
Measured: 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
Measured: Up to 2 weeks post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start9 Feb 2026
- Primary completion30 Sep 2028 (estimated)
- Study completion23 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Roche Diagnostics GmbH
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Roche Diagnostics GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455136
- Sponsor's protocol ID
- RD007282
- Other IDs
- HHSO100201800036C
- Status last verified
- Oct 2026
- First submitted
- 3 Mar 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07455136
- Acronym / sponsor ID
- RD007282
- Conditions
- Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- Roche Diagnostics GmbH
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 23 Nov 2028 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Participants with Suspected TBI | – | Procedure: Blood sample collection |
| Cohort 2: Hospitalized Participants with TBI | – | Procedure: Blood sample collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
- Admitted to the hospital with radiographic evidence of acute TBI
- Admitted to the intensive care unit at risk for decline related to TBI
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample collectionBlood samples from each enrolled participant in CLIN12.1 and/or CLIN12.2 will be collected. | Procedure or surgery | Cohort 1: Participants with Suspected TBI, Cohort 2: Hospitalized Participants with TBI |
Primary outcome
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
8 secondary outcomes
CLIN12.1: Sensitivity of Second Panel of Biomarkers Compared with TBI Diagnosis
Time frame: From Day 1 to 2 weeks post-injury
CLIN12.1: Specificity of Second Panel of Biomarkers Compared with TBI Diagnosis
Time frame: From Day 1 to 2 weeks post-injury
CLIN12.1: Sensitivity of Second Panel of Biomarkers Compared with Neuroworsening Results
Time frame: From Day 1 to 2 weeks post-injury
CLIN12.1: Specificity of Second Panel of Biomarkers Compared with Neuroworsening Results
Time frame: From Day 1 to 2 weeks post-injury
CLIN12.1: Sensitivity of Second Panel of Biomarkers Compared with GOSE-TBI Scores
Time frame: Days 14, 28, and 90
CLIN12.1: Specificity of Second Panel of Biomarkers Compared with GOSE-TBI Scores
Time frame: Days 14, 28, and 90
CLIN12.2: Sensitivity of a Second 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 Second Biomarker Compared with the Development of Secondary Events in Hospitalized Participants with TBI
Time frame: Up to 2 weeks post-injury
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Traumatic Brain Injury
RecruitingPhase 1
Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
Traumatic Brain Injuries, TBI (Traumatic Brain Injury)
Recruiting
Feasibility and Acceptability of an LLM-based Chatbot for Family Caregivers: Evaluation Study
Caregivers
Not yet recruitingObservational study
Prospective Observational Multimodal Neuromonitoring in Adult NSICU Patients
Subarachnoid Hemorrhage, Aneurysmal, Brain Injuries, Traumatic
Not yet recruitingObservational study
The Systemic Nature of Severe Traumatic Brain Injury
Severe Traumatic Brain Injury
Not yet recruitingObservational study
Cognitive Effects of Hyperbaric Oxygen Therapy (HBOT) After a Traumatic Brain Injury
Traumatic Brain Injury, Post-Concussion Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Trials study director
Roche Diagnostics GmbH
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Hoffmann-La Roche at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marian Martinez (+1-815-394-9084, marian.martinez@external.roche.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.