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NCT Number: NCT06042946

Microsurgical Resection of Intramedullary Spinal Cord Metastases

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)

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Functional outcome at 90 days after treatment initiation

    Time frame: 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 outcomes

  1. Functional outcome

    Time frame: at 3, 6 and 12 months after treatment initiation

    modified Japanese Orthopaedic Association Score (mJOA) Range 0-18, with lower scores indicate a more sever myelopathy

  2. Neurological outcome

    Time frame: at 6 and 12 months after treatment initiation

    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

  3. Rate & type of complications

    Time frame: within 90 days after treatment initiation

    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

  4. Functional outcome

    Time frame: at 6 and 12 months 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Felix C. Stengel, MD

CONTACT

[email protected]

+41 71 494 2184

Martin N. Stienen, PD, MD

CONTACT

[email protected]

+41 71 494 2183

Sponsors and collaborators

Lead sponsor

Cantonal Hospital of St. Gallen

Other

Collaborators

  • Insel Gruppe AG, University Hospital Bern
  • Kantonsspital Aarau
  • Kantonsspital Winterthur KSW
  • Klinikum rechts der Isar Technische Universität München
  • Luzerner Kantonsspital
  • Stanford University
  • University Hospital Muenster
  • University Hospital, Geneva
  • University Hospital, Zürich
  • University of Toronto

Registry information

Official study title

Microsurgical Resection of Intramedullary Spinal Cord Metastases - a Retrospective International Multicenter Study

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 21, 2023
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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