NCT07066475|Recruiting
A Registry-Based Cohort Study on the Clinical Outcomes of Spinal Cord Glioma Resection Via the Dorsolateral Sulcus Approach
DLS
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DLS
Sponsor study identifier
observational
100
1 country
1
Study Start
January 1, 2022
Actual (reported)Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Spinal cord gliomas are the most common type of primary intramedullary malignant tumors, with a low incidence and a peak onset age of approximately 35 years. They are slightly more prevalent in males than females. Clinical manifestations vary depending on tumor characteristics and location, typically presenting with axial pain and displaying a tendency for unilateral, infiltrative growth. Prognosis is generally poor, and effective treatment options are limited aside from surgical resection. Common surgical approaches for intramedullary tumor removal include the posterior median sulcus approach, the dorsolateral sulcus approach, and surface entry techniques. Preliminary clinical observations suggest that the dorsolateral sulcus approach may offer superior preservation of neurological function and quality of life. However, due to limited research evaluating the safety and efficacy of different surgical routes, the traditional posterior median sulcus approach remains widely used. This single-center, registry-based cohort study aims to compare the outcomes of spinal cord glioma resection via the dorsolateral sulcus approach versus the posterior median sulcus approach. Patients with laterally located tumors undergoing surgical treatment, classified according to the 2021 WHO criteria, will be included. Neurological function scores and quality-of-life assessments will be used to evaluate prognosis and survival, in order to determine the optimal surgical approach for spinal cord glioma resection.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2022
Actual (reported)June 25, 2025
Actual (reported)July 15, 2025
Actual (reported)December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Extent of resection
The extent of tumor resection was evaluated by comparing the preoperative and postoperative magnetic resonance images, and the criterion for judgment was that the tumor volume decreased by more than 50%.
Preoperative MRI and MRI re-examinations conducted within 3 days after the surgery
Number of Participants with Preserved Dorsal Column Function (Assessed by clinical neurological examination and intraoperative electrophysiological monitoring )
Dorsal column function will be assessed through standardized clinical neurological examination, including evaluation of proprioception (joint position sense), vibration sense, and gait. Dysfunction is defined as the presence of generalized numbness or painful dysesthesias below the surgical level, accompanied by proprioceptive loss and/or gait disturbance. \* This definition is based on previously published clinical criteria for dorsal column dysfunction in patients with intramedullary spinal cord tumors, as described by Manzano et al.
Preoperative, 1 month, 6 months
Pain Level (VAS Score)
Assessment of pain severity using the Visual Analog Scale (VAS), with scores ranging from 0 (no pain) to 100 (worst possible pain).
Preoperative, 1 month postoperative, 6 months postoperative, and 12 months postoperative
SF-36 quality of life metrics
6 months and 12 months postoperative
Progression-Free Survival (PFS)
From date of surgery until tumor progression or death, assessed up to 24 months
Overall Survival (OS)
From date of surgery to death from any cause, assessed up to 36 months
Patients who underwent tumor resection through the dorsolateral sulcus approach
Patients who underwent tumor resection through the posterior median sulcus approach
This is a single-center registry study including patients aged 3-75 years who were diagnosed with spinal cord glioma by histopathology and underwent surgical resection. All participants provided informed consent and were able to complete follow-up assessments.
Beijing Neurosurgical Institute, Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070, China
First Submitted
June 25, 2025
First Posted
July 15, 2025
Study Start
January 1, 2022
Actual (reported)Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Intradurale Spinal Tumors: Management and Treatment
Neurological Functional Status (McCormick Grade)
Evaluation of neurological status using the McCormick Functional Grading Scale to compare surgical approaches. The scale ranges from Grade I (normal gait and function) to Grade IV (severe disability or paraplegia).
Preoperative, 1 month postoperative, 3 months postoperative, 6 months postoperative, and 12 months postoperative
Contact the study team to confirm eligibility.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 23, 2025
Record last verified: 2025-07
The investigators plan to share de-identified individual participant data including baseline characteristics, treatment assignment, primary and secondary outcome measures. Additionally, the investigators will provide the study protocol, data dictionary, and statistical analysis plan. Data will be shared in a secure format to protect participant confidentiality.
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Source: ClinicalTrials.gov.
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