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| Name | Class |
|---|---|
| University Hospital, Zürich | OTHER |
| Insel Gruppe AG, University Hospital Bern | OTHER |
| University Hospital, Geneva | OTHER |
| Kantonsspital Aarau |
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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):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iscm_resection | -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 |
| |
| iscm_radiotherapy | -Adult patients admitted to one of the participating centres and treated for ISCM between 2017 and 2023 by radiotherapy without resection of the ISCM |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microsurgical resection of ISCM | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at 90 days after treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Functional outcome | modified Japanese Orthopaedic Association Score (mJOA) Range 0-18, with lower scores indicate a more sever myelopathy | at 3, 6 and 12 months after treatment initiation |
| Neurological outcome |
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Inclusion Criteria:
Exclusion Criteria:
- Patients under the age of 18
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin N. Stienen, PD, MD | Contact | +41 71 494 2183 | martin.stienen@kssg.ch | |
| Felix C. Stengel, MD | Contact | +41 71 494 2184 | felix.stengel@kssg.ch |
| Name | Affiliation | Role |
|---|---|---|
| Martin N. Stienen, PD, MD | Cantonal Hospital of St. Gallen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cantonal Hospital St. Gallen, Neurosurgery | Recruiting | Sankt Gallen | 9000 | Switzerland |
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| ID | Term |
|---|---|
| D013120 | Spinal Cord Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| OTHER |
| Kantonsspital Winterthur KSW | OTHER |
| Luzerner Kantonsspital | OTHER |
| Klinikum rechts der Isar Technische Universität München | UNKNOWN |
| University Hospital Muenster | OTHER |
| University of Toronto | OTHER |
| Stanford University | OTHER |
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|
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
| 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 | 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. | at 6 and 12 months after treatment initiation |
| D013118 |
| Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |