Spinal Cord MetastasisNCT06042946
Microsurgical Resection of Intramedullary Spinal Cord Metastases
An observational study of Spinal Cord Metastasis and Spinal Cord Tumor Malignant Intramedullary, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Metastasis, Spinal Cord Tumor Malignant Intramedullary, Functional Outcome
- What is being tested?
- Microsurgical resection of ISCM
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2023to 31 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Adult patients admitted to one of the participating centres and treated for ISCM
- Available documentation of admission and postoperative status
Who cannot join
- Patients under the age of 18
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Cantonal Hospital St. Gallen, Neurosurgery
Sankt Gallen, 9000
Martin N. Stienen, PD, MD, +41714942183, martin.stienen@kssg.ch
Felix C. Stengel, MD, +41714942184, felix.stengel@kssg.ch
About this study
Official title: Microsurgical Resection of Intramedullary Spinal Cord Metastases - a Retrospective International Multicenter Study
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.
Read more
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)
- Conditions
- Spinal Cord Metastasis, Spinal Cord Tumor Malignant Intramedullary, Functional Outcome, Radiotherapy; Complications, Spinal Cord Neoplasms
- Being tested
- Microsurgical resection of ISCM
- Keywords
- Spinal cord metastasis
- 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.
Microsurgical resection of ISCMProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Microsurgical resection of ISCM | |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 90 days after treatment initiation
Secondary outcomes (4)
Functional outcome
modified Japanese Orthopaedic Association Score (mJOA) Range 0-18, with lower scores indicate a more sever myelopathy
Measured: 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
Measured: 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
Measured: 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.
Measured: at 6 and 12 months after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Sep 2023
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord MetastasisStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Zürich, Insel Gruppe AG, University Hospital Bern, University Hospital, Geneva, Kantonsspital Aarau, Kantonsspital Winterthur KSW, Luzerner Kantonsspital, Technical University of Munich, University Hospital Muenster, University of Toronto, Stanford University
- Responsible party
- Principal investigator, Felix C. Stengel, MD, Cantonal Hospital of St. Gallen
- Investigators
- Martin N. Stienen, PD, MD, Principal investigator, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042946
- Sponsor's protocol ID
- 2023-00292
- Other IDs
- 2023
- Status last verified
- Aug 2024
- First submitted
- 5 Sep 2023
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microsurgical Resection of Intramedullary Spinal Cord Metastases - a Retrospective International Multicenter Study
- ClinicalTrials.gov ID
- NCT06042946
- Acronym / sponsor ID
- 2023-00292
- Conditions
- Spinal Cord Metastasis, Spinal Cord Tumor Malignant Intramedullary, Functional Outcome, Radiotherapy; Complications, Spinal Cord Neoplasms
- Keywords
- Spinal cord metastasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Collaborators
- University Hospital, Zürich, Insel Gruppe AG, University Hospital Bern, University Hospital, Geneva, Kantonsspital Aarau, Kantonsspital Winterthur KSW, Luzerner Kantonsspital, Technical University of Munich, University Hospital Muenster, University of Toronto, Stanford University
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 21 Sep 2023 (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.
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)
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iscm_resection | – | Procedure: Microsurgical resection of ISCM-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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- Adult patients admitted to one of the participating centres and treated for ISCM
- Available documentation of admission and postoperative status
Key exclusion criteria (1 listed)
- Patients under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microsurgical resection of ISCMMicrosurgical 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. | Procedure or surgery | iscm_resection |
Primary outcome
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.
4 secondary outcomes
Functional outcome
Time frame: at 3, 6 and 12 months after treatment initiation
Neurological outcome
Time frame: at 6 and 12 months after treatment initiation
Rate & type of complications
Time frame: within 90 days after treatment initiation
Functional outcome
Time frame: at 6 and 12 months after treatment initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
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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. This study is not recruiting at the moment.
Martin N. Stienen, PD, MD principal investigator
Cantonal Hospital of St. Gallen
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 Metastasis and Spinal Cord Tumor Malignant Intramedullary, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Aug 2024. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin N. Stienen, PD, MD (+41 71 494 2183, martin.stienen@kssg.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcome at 90 days after treatment initiation (time frame: at 90 days after treatment initiation). 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 21 Aug 2024.