Clinical trial NCT06042946: Microsurgical Resection of Intramedullary Spinal Cord Metastases
Official title: Microsurgical Resection of Intramedullary Spinal Cord Metastases - a Retrospective International Multicenter Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Cord Metastasis
Spinal Cord Tumor Malignant Intramedullary
Functional Outcome
Radiotherapy; Complications
Spinal Cord Neoplasms
Keywords: Spinal cord metastasis
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
Collaborators: name: University Hospital, Zürich
name: Insel Gruppe AG, University Hospital Bern
name: University Hospital, Geneva
name: Kantonsspital Aarau
name: Kantonsspital Winterthur KSW
name: Luzerner Kantonsspital
name: Klinikum rechts der Isar Technische Universität München
name: University Hospital Muenster
name: University of Toronto
name: Stanford University
First posted: 2023-09-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

Brief summary: 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):

* Functional outcome by the McCormick scale and the modified Japanese Orthopaedic Association scale (mJOA) at 6 and 12 months. This is a score evaluating motor function of upper and lower extremities, sensory function of upper extremities and sphincter function / voidance. The mJOA ranges from 0 - 18 points, with higher score values representing better functional outcome. The minimum clinically important difference of the mJOA is 1-2 points, and scores lower than 14 indicate moderate myelopathy, scores lower than 11 indicate severe myelopathy.
* Ambulatory status and continence at 90 days, 6 \& 12 months (determined by mJOA subscores)
* Neurological outcome, measured by American Spinal Cord Injury Association (ASIA)
* Impairment Scale at 90 days, 6 and 12 months
* Rate \& type of complications at 90 days after treatment according to The Novel Therapy
* Disability-Neurology Grade (TDN grade)16
* Overall survival (in days)


Eligibility criteria: Inclusion Criteria:

* Adult patients admitted to one of the participating centres and treated for ISCM
* Available documentation of admission and postoperative status

Exclusion Criteria:

- Patients under the age of 18

Primary outcomes:
measure: Functional outcome at 90 days after treatment initiation
timeFrame: at 90 days after treatment initiation
Secondary outcomes:
measure: Functional outcome
timeFrame: at 3, 6 and 12 months after treatment initiation
measure: Neurological outcome
timeFrame: at 6 and 12 months after treatment initiation
measure: Rate & type of complications
timeFrame: within 90 days after treatment initiation
measure: Functional outcome
timeFrame: at 6 and 12 months after treatment initiation
Other outcomes:
Locations:
city: Saint Gallen
country: Switzerland
facility: Cantonal Hospital St. Gallen, Neurosurgery
Study officials:
affiliation: Cantonal Hospital St. Gallen
name: Martin N. Stienen, PD, MD
role: PRINCIPAL_INVESTIGATOR
References: