Spinal Cord CancerDLSNCT07066475
A Registry-Based Cohort Study on the Clinical Outcomes of Spinal Cord Glioma Resection Via the Dorsolateral Sulcus Approach
An observational study of Spinal Cord Cancer and Spinal Cord Neoplasm, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 75 years
- Conditions the study is for
- Spinal Cord Cancer, Spinal Cord Neoplasm, Spinal Cord Tumor
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2026
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Neurosurgical Institute, Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
About this study
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.
Read the detailed description
Spinal cord gliomas are rare primary intramedullary tumors characterized by lateralized infiltrative growth and limited treatment options beyond surgical resection. Due to the anatomical complexity and functional sensitivity of the spinal cord, the choice of surgical approach significantly impacts postoperative neurological outcomes.
The traditional posterior median sulcus (PMS) approach provides direct midline access for tumor removal but carries a considerable risk of damage to central neural tracts. The dorsolateral sulcus (DLS) approach offers an alternative route for laterally located tumors, potentially sparing critical midline structures and improving functional outcomes.
This single-center, registry-based cohort study aims to evaluate and compare the clinical outcomes of spinal cord glioma resections performed via the DLS and PMS approaches. Patients will be enrolled based on eligibility criteria including lateralized tumor growth confirmed by imaging and histopathology, in accordance with the 2021 WHO classification of CNS tumors.
Primary and secondary outcomes will be assessed using validated clinical scales, including:
Visual Analog Scale (VAS) for pain assessment McCormick Functional Grading Scale Japanese Orthopaedic Association (JOA) Score for spinal cord function SF-36 Health Survey for quality of life evaluation Functional assessment of posterior column integrity Outcome assessments will be performed at five scheduled time points: preoperatively, and postoperatively at 1 month, 3 months, 6 months, and at the last follow-up visit. The study will evaluate neurological recovery, extent of resection, tumor recurrence, postoperative complications, and overall survival. This research aims to identify the optimal surgical approach that maximizes tumor resection while preserving neurological function in patients with spinal cord gliomas.
- Conditions
- Spinal Cord Cancer, Spinal Cord Neoplasm, Spinal Cord Tumor
- Keywords
- Spinal Cord Glioma, Spinal Cord Astrocytes, Intramedullary tumor
- Medical subject headings
- Spinal Cord Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Preoperative, 1 month postoperative, 3 months postoperative, 6 months postoperative, and 12 months postoperative
Secondary outcomes (3)
SF-36 quality of life metrics
Quality of life will be assessed using the 36-Item Short Form Survey (SF-36), a validated questionnaire that evaluates multiple health domains including physical functioning, bodily pain, general health, vitality, social functioning, emotional role, and mental health. Each domain is scored from 0 to 100, with higher scores indicating better health-related quality of life.
Measured: 6 months and 12 months postoperative
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from surgery to the first documented tumor progression or death from any cause. Progression is determined by imaging and/or neurological deterioration.
Measured: From date of surgery until tumor progression or death, assessed up to 24 months
Overall Survival (OS)
Overall survival is defined as the time from surgery to death from any cause. Survival status will be monitored through clinic visits or follow-up contact.
Measured: From date of surgery to death from any cause, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start1 Jan 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord CancerStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066475
- Sponsor's protocol ID
- KY2025-143-02
- Acronym
- DLS
- Status last verified
- Jul 2025
- First submitted
- 25 Jun 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry-Based Cohort Study on the Clinical Outcomes of Spinal Cord Glioma Resection Via the Dorsolateral Sulcus Approach
- ClinicalTrials.gov ID
- NCT07066475
- Acronym / sponsor ID
- DLS / KY2025-143-02
- Conditions
- Spinal Cord Cancer, Spinal Cord Neoplasm, Spinal Cord Tumor
- Keywords
- Spinal Cord Glioma, Spinal Cord Astrocytes, Intramedullary tumor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Spinal cord gliomas are rare primary intramedullary tumors characterized by lateralized infiltrative growth and limited treatment options beyond surgical resection. Due to the anatomical complexity and functional sensitivity of the spinal cord, the choice of surgical approach significantly impacts postoperative neurological outcomes.
The traditional posterior median sulcus (PMS) approach provides direct midline access for tumor removal but carries a considerable risk of damage to central neural tracts. The dorsolateral sulcus (DLS) approach offers an alternative route for laterally located tumors, potentially sparing critical midline structures and improving functional outcomes.
This single-center, registry-based cohort study aims to evaluate and compare the clinical outcomes of spinal cord glioma resections performed via the DLS and PMS approaches. Patients will be enrolled based on eligibility criteria including lateralized tumor growth confirmed by imaging and histopathology, in accordance with the 2021 WHO classification of CNS tumors.
Primary and secondary outcomes will be assessed using validated clinical scales, including:
Visual Analog Scale (VAS) for pain assessment McCormick Functional Grading Scale Japanese Orthopaedic Association (JOA) Score for spinal cord function SF-36 Health Survey for quality of life evaluation Functional assessment of posterior column integrity Outcome assessments will be performed at five scheduled time points: preoperatively, and postoperatively at 1 month, 3 months, 6 months, and at the last follow-up visit. The study will evaluate neurological recovery, extent of resection, tumor recurrence, postoperative complications, and overall survival. This research aims to identify the optimal surgical approach that maximizes tumor resection while preserving neurological function in patients with spinal cord gliomas.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 3 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Extent of resection
Time frame: Preoperative MRI and MRI re-examinations conducted within 3 days after the surgery
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%.
Number of Participants with Preserved Dorsal Column Function (Assessed by clinical neurological examination and intraoperative electrophysiological monitoring )
Time frame: Preoperative, 1 month, 6 months
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.
Pain Level (VAS Score)
Time frame: Preoperative, 1 month postoperative, 6 months postoperative, and 12 months postoperative
Assessment of pain severity using the Visual Analog Scale (VAS), with scores ranging from 0 (no pain) to 100 (worst possible pain).
Neurological Functional Status (McCormick Grade)
Time frame: Preoperative, 1 month postoperative, 3 months postoperative, 6 months postoperative, and 12 months postoperative
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).
3 secondary outcomes
SF-36 quality of life metrics
Time frame: 6 months and 12 months postoperative
Progression-Free Survival (PFS)
Time frame: From date of surgery until tumor progression or death, assessed up to 24 months
Overall Survival (OS)
Time frame: From date of surgery to death from any cause, assessed up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Cancer and Spinal Cord Neoplasm, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wang Yongzhi Wang, MD (+86 13466391736, yongzhiwang_bni@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extent of resection (time frame: Preoperative MRI and MRI re-examinations conducted within 3 days after the surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.