## Protocol Section
### Identification Module
**NCT ID:** NCT06436716

**Brief Title:** Artificial Intelligence Model for Traumatic Cervical Spinal Cord Injury Based on Radiomics and Genomics

**Official Title:** The Second Affiliated Hospital of Nantong University, Nantong First People's Hospital, Nantong University

#### Organization Study ID Info
**ID:** WuCS
#### Organization
**Class:** OTHER
**Full Name:** Affiliated 2 Hospital of Nantong University
### Status Module
#### Completion Date
**Date:** 2027-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-24

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2016-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Affiliated 2 Hospital of Nantong University

#### Responsible Party

**Investigator Affiliation:** Affiliated 2 Hospital of Nantong University

**Investigator Full Name:** Jiawei Jiang

**Investigator Title:** Clinical Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief 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. 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 Module

**Conditions:**

- Spinal Cord Injuries

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 300

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Control: No spinal cord injury

**Intervention Names:**

- Radiation: MRI

**Label:** Control, SCI-1, SCI-2, SCI-3

#### Arm Group 2

**Description:** SCI-1: spinal cord injury and ASIA Grade A and B

**Intervention Names:**

- Radiation: MRI

**Label:** SCI-1

#### Arm Group 3

**Description:** SCI-2: spinal cord injury and ASIA Grade C

**Intervention Names:**

- Radiation: MRI

**Label:** SCI-2

#### Arm Group 4

**Description:** SCI-3: spinal cord injury and ASIA Grade D

**Intervention Names:**

- Radiation: MRI

**Label:** SCI-3

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Control, SCI-1, SCI-2, SCI-3

- SCI-1

- SCI-2

- SCI-3

**Description:** Every patient needs an MRI to assess spinal cord injury. This is one of the clinically necessary examinations.

**Name:** MRI

**Type:** RADIATION

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** MRI image

**Time Frame:** From 2016 to 2027

**Description:** 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.

**Measure:** ASIA scores

**Time Frame:** From 2016 to 2027

#### Secondary Outcomes

**Description:** Years old, no need month nor day

**Measure:** Age

**Time Frame:** From 2016 to 2027

**Description:** male and female

**Measure:** Gender

**Time Frame:** From 2016 to 2027

**Description:** In kilograms

**Measure:** Weight

**Time Frame:** From 2016 to 2027

**Description:** In meters

**Measure:** Height

**Time Frame:** From 2016 to 2027

**Description:** In kg/m\^2

**Measure:** BMI

**Time Frame:** From 2016 to 2027

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. MRI Diagnosis of TCSCI
2. Clinic Diagnosis of TCSCI
3. The injury site must be in cervical spinal cord
4. MRI images of T2WI must be collected within 48 hours after injury
5. Complete and available imaging data, clinical data, including MRI, sex, age

Exclusion Criteria:

1. Spinal cord concussion and MRI scans have no obvious positive performance of spinal cord
2. The quality of MRI images is insufficient or there are serious motion artifacts

**Healthy Volunteers:** True

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** MRI image of patients within 48 hours after TCSCI in The First People's Hospital of Nantong

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Nantong

**Contacts:**

***Contact 1:***

- **Email:** wcsspine@ntu.edu.cn

- **Name:** Chunshuai Wu, Dr

- **Role:** CONTACT

***Contact 2:***

- **Name:** Hongqing Xu, Dr

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** China

**Facility:** Affiliated 2 Hospital of Nantong University

**State:** Jiangsu

**Status:** RECRUITING

**Zip:** 0513

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000013118

- Term: Spinal Cord Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000020196

- Term: Trauma, Nervous System

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M15916

- Name: Spinal Cord Injuries

- Relevance: HIGH

- As Found: Spinal Cord Injury

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M15915

- Name: Spinal Cord Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22023

- Name: Trauma, Nervous System

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000013119

- Term: Spinal Cord Injuries

### Misc Info Module

- Version Holder: 2024-05-31
