An observational study in Spinal Cord Metastasis, Spinal Cord Tumor Malignant Intramedullary and Functional Outcome, sponsored by Cantonal Hospital of St. Gallen. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-21.
Sponsored by Cantonal Hospital of St. Gallen · Observational
The aim of the study is to establish a multi-center, retrospective database for patients with intramedullary spinal cord metastases (ISCM) and analyse the functional outcome in surgically treated ISCM patients.
The hypothesis is that the surgical treatment of selected ISCM patients does not lead to persistent morbidity and does not increase mortality, compared to patients that are treated non-operatively.
Secondary objectives are to assess pre- to postoperative neurological deficits, ambulatory status, and overall survival of surgically treated ISCM patients.
The investigators intend to include a control cohort of patients with ISCM from participating centers, who underwent non-surgical oncological treatment (radiotherapy with or without chemotherapy). This control cohort of patients will be used to match patients with and without surgical treatment.
Primary endpoint (analysed in surgically treated ISCM patients):
Functional outcome at 90 days after treatment initiation, measured by the modified McCormick Scale. This is a score for grading of neurological function in spinal cord conditions.
The McCormick scale ranges from Grade I (neurologically intact) to grade V (paraplegic or quadriplegic). The McCormick scale is suitable for our retrospective study because of its good reproducibility and comparability.
Secondary endpoints (analysed in surgically treated ISCM patients and analysed in matched patients with and without surgical treatment):
105 studies on the registry are indexed under Spinal Cord Neoplasms; 27 are open to participants now.
This study's planned enrollment of 60 is below the median of 150 across 31 observational studies indexed under Spinal Cord Neoplasms.
Browse Spinal Cord Neoplasms studies →Cantonal Hospital of St. Gallen is the lead sponsor of 79 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population consists of patients who have undergone treatment for ISCM at one of the participating hospitals in the period from 2017 to 2023. The study period is chosen, as electronic documentation is available at all hospitals in this time-period. Patients will be identified by generated lists from neurosurgery (microsurgical procedures for ISCM) and radiooncology (radiotherapy for ISCM).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
-Adult patients admitted to one of the participating centres and treated for ISCM between 2017 and 2023 by resection of the ISCM with or without adjuvant radiotherapy
Procedure: Microsurgical resection of ISCM
-Adult patients admitted to one of the participating centres and treated for ISCM between 2017 and 2023 by radiotherapy without resection of the ISCM
Microsurgical resection of ISCM defines the surgical removal of cancerous tumors that have spread to the spinal cord, using advanced microsurgical techniques and equipment like ultrasound, neuromonitoring, ultrasonic aspirator to prevent damage to the spinal cord.
Functional outcome at 90 days after treatment initiation
measured by the modified McCormick Scale. This is a score for grading of neurological function in spinal cord conditions. The McCormick scale ranges from Grade I (neurologically intact) to grade V (paraplegic or quadriplegic). The McCormick scale is suitable for our retrospective study because of its good reproducibility and comparability.
Time frame: at 90 days after treatment initiation
Functional outcome
modified Japanese Orthopaedic Association Score (mJOA) Range 0-18, with lower scores indicate a more sever myelopathy
Time frame: at 3, 6 and 12 months after treatment initiation
Neurological outcome
measured by American Spinal Cord Injury Association (ASIA) Impairment Scale (AIS) A: Complete. No sensory or motor function is preserved in sacral segments S4-S5, no sacral sparing B: Sensory Incomplete. Sensory but not motor function is preserved below the neurological level and includes sacral segments S4-S5, AND No motor function is preserved more than three levels below the motor level on either side of the body C: Motor Incomplete. Motor function is preserved below the neurological level AND More than half of the key muscle functions below the neurological level of injury have a muscle grade of less than 3 (Grades 0-2) D: Motor Incomplete. Motor function is preserved below the neurological level AND At least half (half or more) of the key muscle functions below the neurological level of injury have a muscle grade ≥ 3 E: Normal. If sensation and motor function are graded as normal in all segments AND the patient had prior SCI-related deficits
Time frame: at 6 and 12 months after treatment initiation
Rate & type of complications
Therapy-Disability-Neurology Grade (TDN Grade) Range: Grade 1-5 The Therapy-Disability-Neurology (TDN) grading system is a novel multidimensional classification of complications severity. higher Grades indicate higher severity of complication
Time frame: within 90 days after treatment initiation
Functional outcome
measured by the modified McCormick Scale. This is a score for grading of neurological function in spinal cord conditions. The McCormick scale ranges from Grade I (neurologically intact) to grade V (paraplegic or quadriplegic). The McCormick scale is suitable for our retrospective study because of its good reproducibility and comparability.
Time frame: at 6 and 12 months after treatment initiation
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Cantonal Hospital of St. Gallen