Spinal Cord InjuriesNCT06436716
Artificial Intelligence Model for Traumatic Cervical Spinal Cord Injury Based on Radiomics and Genomics
An observational study of Spinal Cord Injuries, run by Affiliated 2 Hospital of Nantong University at 1 site in China.
Trial summary
Collect standardized, structured, and comprehensive disease-specific information, produce high-quality and accurate clinical data, provide a sample basis for the analysis and mining of spinal cord injury clinical big data, and establish a spinal cord injury-specific disease data platform to serve clinical work. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- MRI
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Dec 2027
- 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: MRI image of patients within 48 hours after TCSCI in The First People's Hospital of Nantong
Who may be able to join
- MRI Diagnosis of TCSCI
- Clinic Diagnosis of TCSCI
- The injury site must be in cervical spinal cord
- MRI images of T2WI must be collected within 48 hours after injury
- Complete and available imaging data, clinical data, including MRI, sex, age
Who cannot join
- Spinal cord concussion and MRI scans have no obvious positive performance of spinal cord
- The quality of MRI images is insufficient or there are serious motion artifacts
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
Affiliated 2 Hospital of Nantong University
Nantong, Jiangsu, 0513
Chunshuai Wu, Dr, wcsspine@ntu.edu.cn
Hongqing Xu, Dr
About this study
Official title: The Second Affiliated Hospital of Nantong University, Nantong First People's Hospital, Nantong University
Collect standardized, structured, and comprehensive disease-specific information, produce high-quality and accurate clinical data, provide a sample basis for the analysis and mining of spinal cord injury clinical big data, and establish a spinal cord injury-specific disease data platform to serve clinical work. Promote multi-center cooperation in spinal cord injury research: Establish a unified, standardized, queryable, and sharable efficient spinal cord clinical research data platform to promote multi-center cooperation in spinal cord injury clinical research and enhance the international competitiveness of this research field. Help the region to prepare for the establishment of a spinal cord injury-specific disease data platform for various hospitals in the region, forming a spinal cord injury-specific disease network center to achieve data sharing.
- Conditions
- Spinal Cord Injuries
- Being tested
- MRI
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIRadiation
Every patient needs an MRI to assess spinal cord injury. This is one of the clinically necessary examinations.
| Study group | Role | What they receive |
|---|---|---|
| Control, SCI-1, SCI-2, SCI-3 | Control: No spinal cord injury Receives: Radiation: MRI | |
| SCI-1 | SCI-1: spinal cord injury and ASIA Grade A and B Receives: Radiation: MRI | |
| SCI-2 | SCI-2: spinal cord injury and ASIA Grade C Receives: Radiation: MRI | |
| SCI-3 | SCI-3: spinal cord injury and ASIA Grade D Receives: Radiation: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI image
original MRI image format DICOM to Nii was based on Python (Version: 3.10.6), and those would be loaded into the MRIcroGMRI imageL software (Version: 12.2). Three spinal surgeons (with 5, 8 and 18 years of experience in interpreting spinal MRI respectively) manually depict the region of interest (ROI) of the lesion area layer by layer, to form three dimensional (3D) volume of interest (VOI). After the primary spinal surgeon finished depicting the injured spinal cord, the senior spinal surgeon checked the quality of ROI and made some adjustments.
Measured: From 2016 to 2027
ASIA scores
ASIA scores means American Spinal Injury Association Impairment Scale. ASIA has 5 grades depends on the severity of spinal cord injury. Grade A :No sensory or motor function is preserved in sacral segments S4-S5, no sacral sparing. Grade B:Sensory but not motor function is preserved below the neurological level and includes sacral segments S4-S5, AND No motor function is preserved more than three levels below the motor level on either side of the body. Grade C: Motor function is preserved below the neurological level AND More than half of the key muscle functions below the neurological level of injury have a muscle grade of less than 3 (Grades 0-2). Grade D: Motor function is preserved below the neurological level AND At least half (half or more) of the key muscle functions below the neurological level of injury have a muscle grade ≥ 3. Grade E: If sensation and motor function are graded as normal in all segments AND the patient had prior SCI-related deficits.
Measured: From 2016 to 2027
Secondary outcomes (5)
Age
Years old, no need month nor day
Measured: From 2016 to 2027
Gender
male and female
Measured: From 2016 to 2027
Weight
In kilograms
Measured: From 2016 to 2027
Height
In meters
Measured: From 2016 to 2027
BMI
In kg/m^2
Measured: From 2016 to 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study startJan 2016
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated 2 Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiawei Jiang, Affiliated 2 Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436716
- Sponsor's protocol ID
- WuCS
- Status last verified
- May 2024
- First submitted
- 15 May 2024
- Last updated
- 31 May 2024
- Results posted
- No
- 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 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Second Affiliated Hospital of Nantong University, Nantong First People's Hospital, Nantong University
- ClinicalTrials.gov ID
- NCT06436716
- Acronym / sponsor ID
- WuCS
- Conditions
- Spinal Cord Injuries
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Affiliated 2 Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 31 May 2024 (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.
Collect standardized, structured, and comprehensive disease-specific information, produce high-quality and accurate clinical data, provide a sample basis for the analysis and mining of spinal cord injury clinical big data, and establish a spinal cord injury-specific disease data platform to serve clinical work. Promote multi-center cooperation in spinal cord injury research: Establish a unified, standardized, queryable, and sharable efficient spinal cord clinical research data platform to promote multi-center cooperation in spinal cord injury clinical research and enhance the international competitiveness of this research field. Help the region to prepare for the establishment of a spinal cord injury-specific disease data platform for various hospitals in the region, forming a spinal cord injury-specific disease network center to achieve data sharing.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control, SCI-1, SCI-2, SCI-3 | – | Radiation: MRIControl: No spinal cord injury |
| SCI-1 | – | Radiation: MRISCI-1: spinal cord injury and ASIA Grade A and B |
| SCI-2 | – | Radiation: MRISCI-2: spinal cord injury and ASIA Grade C |
| SCI-3 | – | Radiation: MRISCI-3: spinal cord injury and ASIA Grade D |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- MRI image of patients within 48 hours after TCSCI in The First People's Hospital of Nantong
Key inclusion criteria (5 listed)
- MRI Diagnosis of TCSCI
- Clinic Diagnosis of TCSCI
- The injury site must be in cervical spinal cord
- MRI images of T2WI must be collected within 48 hours after injury
- Complete and available imaging data, clinical data, including MRI, sex, age
Key exclusion criteria (2 listed)
- Spinal cord concussion and MRI scans have no obvious positive performance of spinal cord
- The quality of MRI images is insufficient or there are serious motion artifacts
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 |
|---|---|---|
| MRIEvery patient needs an MRI to assess spinal cord injury. This is one of the clinically necessary examinations. | Radiation | Control, SCI-1, SCI-2, SCI-3, SCI-1, SCI-2, SCI-3 |
Primary outcome
MRI image
Time frame: From 2016 to 2027
original MRI image format DICOM to Nii was based on Python (Version: 3.10.6), and those would be loaded into the MRIcroGMRI imageL software (Version: 12.2). Three spinal surgeons (with 5, 8 and 18 years of experience in interpreting spinal MRI respectively) manually depict the region of interest (ROI) of the lesion area layer by layer, to form three dimensional (3D) volume of interest (VOI). After the primary spinal surgeon finished depicting the injured spinal cord, the senior spinal surgeon checked the quality of ROI and made some adjustments.
ASIA scores
Time frame: From 2016 to 2027
ASIA scores means American Spinal Injury Association Impairment Scale. ASIA has 5 grades depends on the severity of spinal cord injury. Grade A :No sensory or motor function is preserved in sacral segments S4-S5, no sacral sparing. Grade B:Sensory but not motor function is preserved below the neurological level and includes sacral segments S4-S5, AND No motor function is preserved more than three levels below the motor level on either side of the body. Grade C: Motor function is preserved below the neurological level AND More than half of the key muscle functions below the neurological level of injury have a muscle grade of less than 3 (Grades 0-2). Grade D: Motor function is preserved below the neurological level AND At least half (half or more) of the key muscle functions below the neurological level of injury have a muscle grade ≥ 3. Grade E: If sensation and motor function are graded as normal in all segments AND the patient had prior SCI-related deficits.
5 secondary outcomes
Age
Time frame: From 2016 to 2027
Gender
Time frame: From 2016 to 2027
Weight
Time frame: From 2016 to 2027
Height
Time frame: From 2016 to 2027
BMI
Time frame: From 2016 to 2027
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 31 May 2024.
- 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.
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 Spinal Cord Injuries, run by Affiliated 2 Hospital of Nantong University 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 5 inclusion and 2 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 31 May 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI image (time frame: From 2016 to 2027). The study lists 2 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 31 May 2024.