A Registry-Based Cohort Study on the Clinical Outcomes of Spinal Cord Glioma Resection Via the Dorsolateral Sulcus Approach

NCT07066475 | Recruiting

• 1 other identifier: KY2025-143-02
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Cancer; Spinal Cord Neoplasm; Spinal Cord Tumor

Keywords

Spinal Cord Glioma; Spinal Cord Astrocytes; Intramedullary tumor

Outcome Measures

Primary Outcomes (4)

• 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

• 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

Secondary Outcomes (3)

• 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

Study Arms (2)

DLS Group

Patients who underwent tumor resection through the dorsolateral sulcus approach

PMS Group

Patients who underwent tumor resection through the posterior median sulcus approach

Eligibility Criteria

• Age: 3 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Age between 3 and 75 years
• Undergoing surgical resection of spinal cord tumor
• Histopathological diagnosis of spinal cord glioma based on routine pathological examination
• Availability of complete clinical data and willingness to participate in follow-up
• Informed consent obtained from the patient and/or legal guardians or immediate family members

You may not qualify if:

• Age under 3 years or over 75 years
• Receipt of radiotherapy, chemotherapy, or anti-tumor biological therapy within 1 month prior to enrollment
• Receipt of immunotherapy within 3 months prior to enrollment
• Participation in other clinical trials within 3 months prior to enrollment
• History of severe allergic reactions or known allergy-prone constitution
• Pregnant or breastfeeding women, or individuals of childbearing potential not using adequate contraception
• Presence of other severe medical conditions or uncontrolled infections
• History of drug abuse, substance misuse, chronic alcoholism, or HIV infection
• Uncontrolled epileptic seizures or psychiatric disorders resulting in loss of self-control

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Neurosurgical Institute, Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

RECRUITING

MeSH Terms

Conditions

Spinal Cord Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Wang Yongzhi Wang, MD

CONTACT

+86 13466391736; yongzhiwang_bni@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 15, 2025
• Study Start: January 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Start date: Within 6 months after study completion and publication of results. End date: 5 years after the start date.
• Access Criteria: Access to the de-identified individual participant data (IPD) and supporting documents will be granted only to qualified researchers who submit a formal request describing their research purpose. Requests will be reviewed by the study team for approval. Approved applicants will be required to sign a data use agreement before receiving access. Data will be shared through a secure platform to ensure confidentiality and proper use.

Locations

CN (1)