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

Not Applicable

Completed

• Conditions: Cancer; Cervical spine dumbbell tumors

• Registration Number: ISRCTN10253765
• Lead Sponsor: China-Japan Union Hospital of Jilin University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-12-31
• Study Start: 2024-08-22
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 144

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>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.<br>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.<br>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.