New scoring system for neck tumors: Improving surgical planning and patient outcomes

ISRCTN	ISRCTN10253765
DOI	https://doi.org/10.1186/ISRCTN10253765
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	China-Japan Union Hospital of Jilin University
Funder	China-Japan Union Hospital of Jilin University

Submission date: 20/08/2024
Registration date: 22/08/2024
Last edited: 22/08/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
This study is focused on improving the safety and effectiveness of surgeries for patients with a specific type of tumor in the neck and spine, known as dumbbell tumors. These tumors can affect both the spinal canal and areas outside of it, making surgery complicated. The aim of the study is to develop and test a new scoring and classification system that can help doctors plan these surgeries better. By using this system, doctors hope to reduce the risks of complications after surgery and improve recovery for patients.

Who can participate?
The study involved 144 patients who had dumbbell tumors in the cervical (neck) area of the spine and were scheduled for surgery. Participants were those who required surgical treatment and were willing to undergo the procedures being studied.

What does the study involve?
Participants in the study underwent surgery to remove their tumors. Before surgery, doctors used advanced imaging techniques, like MRI and special CT scans, to gather detailed information about the tumors. This information was then used to score and classify the tumors based on their size, location, and how close they were to important structures like the spinal cord and arteries. This classification helped guide the surgical approach.

What are the possible benefits and risks of participating?
No additional risks from routine treatment

Where is the study run from?
China-Japan Union Hospital of Jilin University (China)

When is the study starting and how long is it expected to run for?
January 2016 to December 2023

Who is funding the study?
China-Japan Union Hospital of Jilin University (China)

Who is the main contact?
Dr Yongchuan Guo, gyc@jlu.edu.cn

Contact information

Prof YONGCHUAN GUO
Public, Scientific, Principal investigator

Jilin University Second Hospital Bethune
Changchun
130000
China

ORCID ID	0000-0001-6784-5022
Phone	+86 13504310682
Email	gyc@jlu.edu.cn

Mr Fan Li
Public, Scientific

The First Affiliated Hospital of Xinxiang Medical University
xinxiang
453000
China

Phone	13137306977
Email	18237171779@163.com

Mr Zhao Li
Public, Scientific

China-Japan Union Hospital of Jilin University
changchun
130000
China

Phone	183894870540
Email	414306497@qq.com

Mrs Xin Li
Public, Scientific

The Second Hospital of Jilin University
changchun
130000
China

Phone	18043616063
Email	jdeylx610430@jlu.edu.cn

Study information

Primary study design	Observational
Study design	Single-center retrospective observational study
Secondary study design	Cohort study
Participant information sheet	45968 PIS Participant Information Sheet EN.pdf
Scientific title	Application of a novel scoring and classification method in surgery for primary cervical spine dumbbell tumors
Study acronym	CSDT-SCS
Study objectives	1. A new scoring and classification system can be developed for cervical dumbbell tumors based on their anatomical characteristics and growth patterns 2. This new scoring and classification system will provide more accurate guidance for surgical planning compared to existing systems 3. The application of this new system will lead to improved surgical outcomes and reduced complications in patients with cervical dumbbell tumors 4. The new system will demonstrate high inter-observer reliability and reproducibility among different surgeons
Ethics approval(s)	Approved 24/06/2024, Ethics Committee of the Second Hospital of Jilin University (Jilin University Second Hospital Bethune, Changchun, 130000, China; +86-0431-81136334 ; 1312600916@qq.com), ref: No. 264 of 2024
Health condition(s) or problem(s) studied	Cervical spine dumbbell tumors
Intervention	This study does not involve any direct interventions on patients. The research process involves the following steps: Retrospective review of medical records and imaging data of adult patients who underwent surgical treatment for cervical dumbbell tumors. Development of a new scoring and classification system based on the anatomical characteristics and growth patterns of cervical dumbbell tumors observed in the collected data. Application of the new scoring and classification system to the existing patient data to evaluate its effectiveness in surgical planning and outcome prediction. Analysis of surgical outcomes and complications in relation to the new scoring and classification system. Assessment of inter-observer reliability of the new system through independent evaluation by multiple surgeons.
Intervention type	Other
Primary outcome measure(s)	The effectiveness of the new scoring and classification system for cervical dumbbell tumors is assessed by its ability to predict surgical outcomes and complications. This is measured by: 1. The correlation between the preoperative tumor score/classification and the extent of surgical resection (complete vs. partial) as determined by postoperative imaging at 3 months post-surgery. 2. The association between the preoperative tumor score/classification and the occurrence of surgical complications, evaluated during the immediate postoperative period and at follow-up visits at 1, 3, and 6 months post-surgery. 3. Inter-observer reliability of the new system, measured using the intraclass correlation coefficient (ICC) for continuous scores and Cohen's kappa for categorical classifications, assessed by independent evaluations from at least three neurosurgeons.
Key secondary outcome measure(s)	1. Neurological function improvement measured using the Japanese Orthopaedic Association (JOA) score at baseline (preoperative) and at 3, 6, and 12 months postoperatively. 2. Pain reduction assessed using the Visual Analog Scale (VAS) at baseline (preoperative) and at 1, 3, 6, and 12 months postoperatively. 3. Quality of life changes evaluated using the Short Form-36 (SF-36) questionnaire at baseline (preoperative) and at 6 and 12 months postoperatively. 4. Tumor recurrence rate determined by follow-up MRI scans at 12 months and annually thereafter for 5 years post-surgery. 5. Long-term surgical complication rates (e.g., cerebrospinal fluid leakage, wound infection) assessed during follow-up visits at 1, 3, 6, and 12 months postoperatively, and annually thereafter for 5 years. 6. The correlation between tumor location (as classified by the new system) and the surgical approach chosen, analyzed retrospectively from surgical records. 7. Patient satisfaction with surgical outcomes measured using a custom 5-point Likert scale questionnaire at 6 and 12 months postoperatively.
Completion date	31/12/2023

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	23 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	200
Total final enrolment	144
Key inclusion criteria	1. Adult patients aged 18 years or older at the time of surgery 2. Diagnosed with cervical dumbbell tumor confirmed by MRI 3. Underwent surgical treatment for the tumor between January 1, 2010 and December 31, 2020 4. Complete medical records available, including: 4.1. Preoperative imaging (MRI and/or CT scans) 4.2. Detailed surgical records 4.3. Postoperative follow-up data for at least 12 months 5. Tumor histologically confirmed as one of the following types: 5.1. Schwannoma 5.2. Neurofibroma 5.3. Other nerve sheath tumors 6. Ability to provide informed consent for the use of medical data in research (or appropriate proxy consent if patient is incapacitated) 7. Patients with both primary and recurrent cervical dumbbell tumors are eligible
Key exclusion criteria	1. Patients younger than 18 years at the time of surgery 2. Incomplete medical records or imaging data, including: 2.1. Missing preoperative MRI or CT scans 2.2. Incomplete surgical records 2.3. Less than 12 months of postoperative follow-up data 3. Patients who underwent non-surgical treatment for their cervical dumbbell tumor 4. Patients with a history of previous cervical spine surgery unrelated to the dumbbell tumor 5. Patients with concurrent spinal cord tumors not classified as dumbbell tumors 6. Patients with severe comorbidities that significantly impact neurological function or surgical outcomes, such as: 6.1. Advanced neurodegenerative diseases (e.g., advanced Parkinson's disease, multiple sclerosis) 6.2. Severe spinal deformities 6.3. Active systemic malignancies 7. Pregnant women at the time of surgery 8. Patients unable to provide informed consent for the use of their medical data in research (and no appropriate proxy available) 9. Tumors histologically confirmed to be types other than schwannomas, neurofibromas, or nerve sheath tumors 10. Patients who received preoperative radiotherapy or chemotherapy for the cervical dumbbell tumor
Date of first enrolment	01/01/2016
Date of final enrolment	31/12/2023

Locations

Countries of recruitment

China

Study participating centres

China-Japan Union Hospital of Jilin University

No. 126 Sendai Street, Changchun City, Jilin Province
Changchun
130000
China

The Second Hospital of Jilin University

No. 218 Ziqiang Street, Changchun City, Jilin Province
Changchun
130000
China

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	What data will be shared: De-identified individual participant data that underlie the results reported in the main publication, including demographic information, clinical characteristics, imaging findings, surgical details, and outcome measures. What additional, related documents will be available: Study protocol, statistical analysis plan, informed consent form, and clinical study report. When data will be available: Data will be available beginning 9 months and ending 36 months following article publication. With whom data will be shared: Researchers who provide a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee. For what types of analyses: To achieve aims in the approved proposal. By what mechanism data will be made available: Proposals should be directed to gyc@jlu.edu.cn. To gain access, data requestors will need to sign a data access agreement and obtain necessary ethical approvals for their proposed use of the data. Data sharing restrictions: Data will be de-identified in compliance with local privacy laws. Users must agree not to attempt to re-identify participants and to use the data only for the approved purpose. Data security: Data will be shared via a secure, password-protected data sharing platform. This plan is subject to change to protect participant privacy and comply with evolving data protection regulations.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet			22/08/2024	No	Yes
Participant information sheet	in Chinese		22/08/2024	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	in Chinese		22/08/2024	No	No
Statistical Analysis Plan	in Chinese		22/08/2024	No	No

Additional files

45968 Research Protocol CN.pdf: in Chinese
45968 Statistical Analysis Plan CN.pdf: in Chinese
45968 PIS Participant Information Sheet CN.pdf: in Chinese
45968 PIS Participant Information Sheet EN.pdf: Participant information sheet

Editorial Notes

22/08/2024: Trial's existence confirmed by Ethics Committee of the Second Hospital of Jilin University.