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

StatusEnrolling by Invitation
PhaseNot specified
Started2021-06-01
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 88 months later across 2 updates Nov 11, 2022 → Apr 2030
See other at-risk trials from University of California, San Francisco

Amendment history

2026-09-10
Study Status v11
Primary completion pushed: 2030-02 → 2030-04
Trial status changed: Active, Not Recruiting → Enrolling by Invitation
Primary completion pushed: 2022-11-11 → 2030-02
2026-09-09
Active, Not Recruiting→Enrolling by Invitation Study Status, Study Design v10
Trial statusActive, Not Recruiting→Enrolling by Invitation
Primary completion date2022-11-11→2030-02
Completion date2030-04-09→2030-04
2026-08-31
Study Status v9
Re-verified, no change to tracked fields
2025-04-09
Completed→Active, Not Recruiting Study Status v8
Trial statusCompleted→Active, Not Recruiting
Completion date2023-01-31→2030-04-09
2023-03-13
Enrolling by Invitation→Completed Study Status, Study Design v7
Trial statusEnrolling by Invitation→Completed
Primary completion dateestimated 2023-08→confirmed 2022-11-11
Completion dateestimated 2023-09→confirmed 2023-01-31
Show 6 earlier versions
2022-09-19
Study Status v6
Primary completion date2022-08→2023-08
Completion date2022-09→2023-09
2021-11-09
Study Status v5
Primary completion date2022-03→2022-08
Completion date2022-06→2022-09
2021-06-02
Not Yet Recruiting→Enrolling by Invitation Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Enrolling by Invitation
Primary completion date2022-01→2022-03
Completion date2022-04→2022-06
Start dateestimated 2021-04→confirmed 2021-06-01
Study sitescontacts updated at 5 of 5 sites
2021-03-15
Study Status v3
Primary completion date2021-11→2022-01
Completion date2022-02→2022-04
Start date2021-02→2021-04
2020-12-11
Study Status v2
Primary completion date2021-07→2021-11
Completion date2021-10→2022-02
Start date2020-10→2021-02
2020-10-26
Study Status, Study Description, Outcome Measures, IPDSharing v1
Primary endpoints12 entries, revised
3T3 Tesla Brain Structural and Functional Magnetic Resonance Imaging (MRI) 3T3 Tesla Brain Structural and Functional Magnetic Resonance Imaging (MRI) 3T3 Tesla Brain Structural and Functional Magnetic Resonance Imaging (MRI)
Study description+1 characters
[...] d the world's largest collection of TBI imaging studies and biospecimensbio-specimens. The study results are already being adopted into clinical [...] TBI mechanistic endophenotypes for use in clinical trials. SPECIFICSpecific AIMAim FORfor TRACK-TBI PRECISIONPrecision MEDICINEMedicine PHASEPhase 2-OPTIONOption 1: To validate early and ultra-early blood based and novel [...]
2020-10-20
Original filing
This study is being conducted to validate early and ultra-early blood-based and novel imaging biomarkers of Diffuse Axonal Injury (DAI), Microvascular Injury (MVI), and neuroinflammation that may serve as predictive and pharmacodynamic biomarkers in a new cohort of moderate-severe TRACK-TBI subjects. The study team will enroll a cohort of moderate to severe TBI subjects (N=50), stratified according to VA/DoD criteria for these injury severities through the existing TRACK-TBI network sites to obtain novel advanced neuroimaging and more frequent biomarker sampling. Subjects will be assessed over 3 months.
Trial Details
NCT Number NCT04602806
Lead Sponsor University of California, San Francisco
Collaborators: U.S. Army Medical Research and Development Command
Conditions Traumatic Brain Injury
Enrollment 50 participants
Start Date 2021-06-01
Primary Completion 2030-04 (estimated)
Study Completion 2030-04 (estimated)
Updated on ClinicalTrials.gov 2026-09-14