Actively Recruiting
Microsurgical Resection of Intramedullary Spinal Cord Metastases - a Retrospective International Multicenter Study
Led by Cantonal Hospital of St. Gallen · Updated on 2024-08-21
60
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
Sponsors
C
Cantonal Hospital of St. Gallen
Lead Sponsor
U
University Hospital, Zürich
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are creating a multi-center retrospective database to study patients with intramedullary spinal cord metastases (ISCM). The study aims to compare the functional outcomes of patients who underwent surgical removal of ISCM tumors to those treated non-surgically with radiotherapy, with or without chemotherapy. The main goal is to see if surgery affects long-term neurological function, morbidity, or mortality. The study involves two groups: one receiving microsurgical resection of ISCM tumors using advanced techniques to avoid spinal cord damage, and a control group treated with radiotherapy alone. Researchers will analyze patients treated between 2017 and 2023 across several centers. Outcomes will be assessed at 90 days, 6 months, and 12 months after treatment initiation to measure neurological function, ambulatory status, complications, and survival. Participants will have their neurological and functional status reviewed through scales like the modified McCormick Scale, the modified Japanese Orthopaedic Association scale (mJOA), and the ASIA Impairment Scale. Researchers will also monitor complication rates and overall survival. The study is observational and retrospective, lasting until July 2025, with no intervention assigned during the study period beyond what patients received previously.
CONDITIONS
Brief Title
Microsurgical Resection of Intramedullary Spinal Cord Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients admitted to one of the participating centres and treated for ISCM
- Available documentation of admission and postoperative status
You will not qualify if you...
- Patients under the age of 18
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 90 days after treatment initiation
Participants undergo microsurgical resection of intramedullary spinal cord metastases and receive immediate post-operative care.
Approximately 1 surgical procedure and follow-up visits during the first 90 days
Duration - Up to 12 months after treatment initiation
Participants are monitored for functional and neurological outcomes and complications after surgery for up to 12 months.
Follow-up visits at 3, 6, and 12 months after treatment initiation
Trial Site Locations
Total: 1 location
1
Cantonal Hospital St. Gallen, Neurosurgery
Sankt Gallen, Switzerland, 9000
Actively Recruiting
Research Team
M
Martin N. Stienen, PD, MD
F
Felix C. Stengel, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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