BiomarkersNCT05881226
Application of Biomarkers in Neurological Diseases
An observational study of Biomarkers, run by Yi Yang at 1 site in China.
Trial summary
To explore the predictive and diagnostic role of biomarkers in patients with neurological diseases. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Biomarkers
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 5 Jun 2023to 1 Dec 2031
- How long will I take part?
- 1 Year
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with neurological diseases admitted to hospital/emergency department.
Who may be able to join
- Patients with neurological diseases;
- Subjects or legal agents agree to participate in the study and sign the informed consent.
Who cannot join
- Participating in other clinical investigators;
- Unwilling to be followed up or poor treatment compliance;
- Other conditions considered unsuitable for inclusion by the researchers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Hospital of Jilin University
Changchun, Jilin, 130000
Yi Yang, MD, PhD, doctoryangyi@163.com
About this study
To explore the predictive and diagnostic role of biomarkers in patients with neurological diseases.
Read the detailed description
With the rise and continuous development of omics technology and bioinformatics technology, some scholars have applied proteomics technology and metabolomics technology to study the brain tissue, plasma and CSF of patients with nervous system diseases, so as to screen out potential biomarkers, with a view to providing new research ideas for pathogenesis and early diagnosis of neurological diseases. At present, the research on some novel biomarkers is still in its infancy, and many key problems remain to be solved. It is necessary to further determine the expression level of biomarkers in normal human body and the characteristics of biomarkers in patients with neurological diseases.
- Conditions
- Biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients admitted to hospital/emergency department with neurological diseases | All clinical data, laboratory data and imaging data of patients at baseline and follow-up were collected, as well as blood and tissue samples that did not affect the diagnosis and treatment of patients after obtaining the consent of patients at different time points in the acute and chronic phases. |
What is being measured
The primary outcome is the main question the study is designed to answer.
mRS score in 90 days
The proportion of 3-month good functional outcome (mRS Score 0-2) in patients with neurological diseases was evaluated by mRS Score
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start5 Jun 2023
- Primary completion1 Dec 2030 (estimated)
- Study completion1 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BiomarkersStudies of the same condition, open and under way.
- 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
- 3,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Yi Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yi Yang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881226
- Sponsor's protocol ID
- Bio-Neuro
- Status last verified
- Feb 2024
- First submitted
- 15 May 2023
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Biomarkers in Neurological Diseases
- ClinicalTrials.gov ID
- NCT05881226
- Acronym / sponsor ID
- Bio-Neuro
- Conditions
- Biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Yi YangUniversity, hospital or other
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 1 Dec 2031 (estimated)
- First posted
- 31 May 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.
To explore the predictive and diagnostic role of biomarkers in patients with neurological diseases.
Detailed description
With the rise and continuous development of omics technology and bioinformatics technology, some scholars have applied proteomics technology and metabolomics technology to study the brain tissue, plasma and CSF of patients with nervous system diseases, so as to screen out potential biomarkers, with a view to providing new research ideas for pathogenesis and early diagnosis of neurological diseases. At present, the research on some novel biomarkers is still in its infancy, and many key problems remain to be solved. It is necessary to further determine the expression level of biomarkers in normal human body and the characteristics of biomarkers in patients with neurological diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients admitted to hospital/emergency department with neurological diseases | – | –All clinical data, laboratory data and imaging data of patients at baseline and follow-up were collected, as well as blood and tissue samples that did not affect the diagnosis and treatment of patients after obtaining the consent of patients at different time points in the acute and chronic phases. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with neurological diseases admitted to hospital/emergency department.
Key inclusion criteria (2 listed)
- Patients with neurological diseases;
- Subjects or legal agents agree to participate in the study and sign the informed consent.
Key exclusion criteria (3 listed)
- Participating in other clinical investigators;
- Unwilling to be followed up or poor treatment compliance;
- Other conditions considered unsuitable for inclusion by the researchers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mRS score in 90 days
Time frame: 3 months
The proportion of 3-month good functional outcome (mRS Score 0-2) in patients with neurological diseases was evaluated by mRS Score
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 1 Mar 2024.
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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.
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 Biomarkers, run by Yi Yang 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 2 inclusion and 3 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 1 Mar 2024. 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?
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 Yi YY Yang, Ph.D. (18186872986 ext. 86, doctoryangyi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mRS score in 90 days (time frame: 3 months). 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 1 Mar 2024.