Brain Injuries, TraumaticMOSS-FASTNCT05778123
Multiomic Analysis of Body Fluid in Acute Traumatic Brain Injury
An observational study of Brain Injuries, Traumatic, run by RenJi Hospital at 1 site in China.
Trial summary
The goal of this experimental observation study is to figure out differently expressed biomarkers in body fluid in traumatic brain injury patients. The main questions it aims to answer is: Which RNA, protein and metabolites are differently expressed in lesion tissues? What molecular mechanism is participated in TBI?… Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Brain Injuries, Traumatic
- What is being tested?
- Type of disease
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with severe traumatic brain injury or hydrocephalus.
Who may be able to join
- Age >18 and <65
- Within 12 hours after brain injury
- Control group is hydrocephalus
- GCS ≥3 and ≤8
- Closed brain injury with frontotemporal contusion
- Need emergency intracranial hematoma evacuating or cerebrospinal fluid shunting operation
- Patient's agents are informed and consent the research
Who cannot join
- With TBI, stroke, ICH or intracranial tumor history
- Death within 24 hours
- Immunosuppression state
- Severe organ dysfunction
- Complicated infective disease
- Pregnant
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality
Junfeng Feng, +8613611860825
About this study
The goal of this experimental observation study is to figure out differently expressed biomarkers in body fluid in traumatic brain injury patients. The main questions it aims to answer is:
- Which RNA, protein and metabolites are differently expressed in lesion tissues?
- What molecular mechanism is participated in TBI? Participants will be treated by emergency operation, and their body fluid samples will be collected in emergency room and during the operation.
- Conditions
- Brain Injuries, Traumatic
- Being tested
- Type of disease
- Keywords
- Traumatic brain injury, Body fluid, Biomarker, Multiomic analysis
- 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.
Type of diseaseOther
Different types of pathogen: brain injury by trauma or hydrocephalus due to various diseases.
| Study group | Role | What they receive |
|---|---|---|
| TBI | Patients with traumatic brain injury. Receives: Other: Type of disease | |
| Control | Patients with hydrocephalus. Receives: Other: Type of disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
RNA biomarkers in patients' blood & cerebrospinal fluid assessed by transcriptome bioinformatic analysis
Patients' blood and cerebrospinal fluid will be collected in emergency room and operation room respectively. Then these samples will be immediately prepared to be detected through transcriptome sequencing. The results of transcriptome sequencing will be further analyzed and compared with control group to filter potential RNA biomarkers in blood and cerebrospinal fluid of severe TBI patients.
Measured: Immediately after collecting blood & cerebrospinal fluid
Protein biomarkers in patients' blood & cerebrospinal fluid assessed by proteomic bioinformatic analysis
Patients' blood and cerebrospinal fluid will be collected in emergency room and operation room respectively. Then these samples will be immediately prepared to be detected through proteomics mass spectrometry. The results of proteomic will be further analyzed and compared with control group to filter potential protein biomarkers in blood and cerebrospinal fluid of severe TBI patients.
Measured: Immediately after collecting blood & cerebrospinal fluid
Metabolite biomarkers in patients' blood & cerebrospinal fluid assessed by metabolomic bioinformatic analysis
Patients' blood and cerebrospinal fluid will be collected in emergency room and operation room respectively. Then these samples will be immediately prepared to be detected through metabolomic mass spectrometry. The results of metabolomic will be further analyzed and compared with control group to filter potential metabolite biomarkers in blood and cerebrospinal fluid of severe TBI patients.
Measured: Immediately after collecting blood & cerebrospinal fluid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start1 Apr 2023
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junfeng Feng, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778123
- Sponsor's protocol ID
- LY2023-018-B
- Acronym
- MOSS-FAST
- Status last verified
- May 2023
- First submitted
- 5 Feb 2023
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiomic Analysis of Body Fluid in Acute Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT05778123
- Acronym / sponsor ID
- MOSS-FAST / LY2023-018-B
- Conditions
- Brain Injuries, Traumatic
- Keywords
- Traumatic brain injury, Body fluid, Biomarker, Multiomic analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Mar 2023 (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 goal of this experimental observation study is to figure out differently expressed biomarkers in body fluid in traumatic brain injury patients. The main questions it aims to answer is:
- Which RNA, protein and metabolites are differently expressed in lesion tissues?
- What molecular mechanism is participated in TBI? Participants will be treated by emergency operation, and their body fluid samples will be collected in emergency room and during the operation.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TBI | – | Other: Type of diseasePatients with traumatic brain injury. |
| Control | – | Other: Type of diseasePatients with hydrocephalus. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with severe traumatic brain injury or hydrocephalus.
Key inclusion criteria (7 listed)
- Age >18 and <65
- Within 12 hours after brain injury
- Control group is hydrocephalus
- GCS ≥3 and ≤8
- Closed brain injury with frontotemporal contusion
Key exclusion criteria (6 listed)
- With TBI, stroke, ICH or intracranial tumor history
- Death within 24 hours
- Immunosuppression state
- Severe organ dysfunction
- Complicated infective disease
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 |
|---|---|---|
| Type of diseaseDifferent types of pathogen: brain injury by trauma or hydrocephalus due to various diseases. | Other | Control, TBI |
Primary outcome
RNA biomarkers in patients' blood & cerebrospinal fluid assessed by transcriptome bioinformatic analysis
Time frame: Immediately after collecting blood & cerebrospinal fluid
Patients' blood and cerebrospinal fluid will be collected in emergency room and operation room respectively. Then these samples will be immediately prepared to be detected through transcriptome sequencing. The results of transcriptome sequencing will be further analyzed and compared with control group to filter potential RNA biomarkers in blood and cerebrospinal fluid of severe TBI patients.
Protein biomarkers in patients' blood & cerebrospinal fluid assessed by proteomic bioinformatic analysis
Time frame: Immediately after collecting blood & cerebrospinal fluid
Patients' blood and cerebrospinal fluid will be collected in emergency room and operation room respectively. Then these samples will be immediately prepared to be detected through proteomics mass spectrometry. The results of proteomic will be further analyzed and compared with control group to filter potential protein biomarkers in blood and cerebrospinal fluid of severe TBI patients.
Metabolite biomarkers in patients' blood & cerebrospinal fluid assessed by metabolomic bioinformatic analysis
Time frame: Immediately after collecting blood & cerebrospinal fluid
Patients' blood and cerebrospinal fluid will be collected in emergency room and operation room respectively. Then these samples will be immediately prepared to be detected through metabolomic mass spectrometry. The results of metabolomic will be further analyzed and compared with control group to filter potential metabolite biomarkers in blood and cerebrospinal fluid of severe TBI patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries, Traumatic, run by RenJi Hospital at 1 site in China.
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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhenghui He (+8613585916217, hezhenghui8@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RNA biomarkers in patients' blood & cerebrospinal fluid assessed by transcriptome bioinformatic analysis (time frame: Immediately after collecting blood & cerebrospinal fluid). The study lists 3 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 3 May 2023.