Spinal TumorsSSTRNCT06869746
Swiss Spinal Tumor Registry (Swiss-STR)
An observational study of Spinal Tumors and Surgical Treatment, run by Luzerner Kantonsspital at 1 site in Switzerland.
Trial summary
The Swiss Spinal Tumor Registry is a prospective REDCap-based registry, collecting data of surgically treated patients with primary and metastatic tumors of the spine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Tumors, Surgical Treatment
- How many people
- 250 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2023to 31 Dec 2032
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult patients suffering from primary or metastatic spinal tumors, undergoing surgery
Who may be able to join
- Diagnosis of primary spinal tumor
- Diagnosis of secondary (metastatic) spinal tumor
- Indication for surgical treatment is present
- Patient age: =/>18 years
Who cannot join
- Withdrawal of consent
- Withdrawal from initially planned surgical procedure
- Patient age: <18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Lucerne Cantonal Hospital
Lucerne, Canton of Lucerne, 6000
Severin Rüssli, MD, +41412054555, severin.ruessli@luks.ch
Sabrina Bäbler, MD, +41412051624, sabrina.bäbler@luks.ch
About this study
The Swiss Spinal Tumor Registry is a prospective REDCap-based registry, collecting data of surgically treated patients with primary and metastatic tumors of the spine.
Read the detailed description
Tumors of the vertebral column consist of primary spinal tumors and malignancies metastasizing to the spine. While primary spine tumors represent a rare condition, metastases to the spine have gradually increased over past decades because of increases in aging population and continued advances in cancer therapy with improved survival times across multiple cancer subtypes. Metastases to the vertebral column are found in up to 70% of cancer patients, with 10% of patients demonstrating epidural spinal cord compression. Therefore, many cancer patients may face spinal surgical intervention at some point of their chronic illness. Numerous surgical treatment options are currently available, ranging from simple cement augmentation over decompression of neural elements to extended instrumentation or reconstruction of the spine, including hybrid procedures that combine these techniques. However, precise surgical treatment guidelines do not exist, likely due to the absence of robust, long-term clinical outcomes data in these patients, and the overall heterogeneous nature of spinal tumors. The primary goal of Swiss-STR is to inform on the effectiveness of current practice in spinal oncology and its impact on patient outcomes. Furthermore, it will help to better categorize the different clinical presentations of spinal tumors, thereby facilitating treatment recommendations, assessing the socio-economic burden of this condition to the healthcare system, and improving the quality of care. In cases of rare tumors, multicenter data pooling will fill significant data gaps, allowing a better understanding of these entities. Finally, the approach is to first build and implement a high-quality registry with efficient electronic data capture strategies across hospital sites in Switzerland, with the potential to later expand internationally, providing opportunities for future international scientific collaboration to push the envelope in cancer research further.
- Conditions
- Spinal Tumors, Surgical Treatment
- Keywords
- Spinal Tumor, Spinal 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.
| Study group | Role | What they receive |
|---|---|---|
| Swiss-STR Cohort | Patients with primary or metastatic spinal tumors undergoing surgical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Outcome as assessed by Karnofsky Performance Status Scale
Rating in 10% steps
- 100 Normal no complaints; no evidence of disease.
- 90 Able to carry on normal activity; minor signs or symptoms of disease.
- 80 Normal activity with effort; some signs or symptoms of disease.
- 70 Cares for self; unable to carry on normal activity or to do active work.
- 60 Requires occasional assistance, but is able to care for most of his personal needs.
- 50 Requires considerable assistance and frequent medical care.
- 40 Disabled; requires special care and assistance.
- 30 Severely disabled; hospital admission is indicated although death is not imminent.
- 20 Very sick; hospital admission necessary; active supportive treatment necessary.
- 10 Moribund; fatal processes progressing rapidly.
- 0 Dead
Measured: Through study completion, an average of 1 year
Physical performance assessed by the Timed-Up-and-Go-Test (TUG)
Timed-Up-and-Go-Test in seconds
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start1 Jan 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal TumorsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edin Nevzati, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869746
- Sponsor's protocol ID
- Swiss-STR
- Acronym
- SSTR
- Status last verified
- Dec 2024
- First submitted
- 3 Feb 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD
Publications
Nevzati E, Poletti N, Spiessberger A, Babler S, Studer G, Riklin C, Diebold J, Chatain GP, Finn M, Witt JP, Moser M, Mariani L. Establishing the Swiss Spinal Tumor Registry (Swiss-STR): a prospective observation of surgical treatment patterns and long-term outcomes in patients with primary and metastatic spinal tumors. Front Surg. 2023 Jul 28;10:1222595. doi: 10.3389/fsurg.2023.1222595. eCollection 2023.
PubMed 37576924
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swiss Spinal Tumor Registry (Swiss-STR)
- ClinicalTrials.gov ID
- NCT06869746
- Acronym / sponsor ID
- SSTR / Swiss-STR
- Conditions
- Spinal Tumors, Surgical Treatment
- Keywords
- Spinal Tumor, Spinal Metastasis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 11 Mar 2025 (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 Swiss Spinal Tumor Registry is a prospective REDCap-based registry, collecting data of surgically treated patients with primary and metastatic tumors of the spine.
Detailed description
Tumors of the vertebral column consist of primary spinal tumors and malignancies metastasizing to the spine. While primary spine tumors represent a rare condition, metastases to the spine have gradually increased over past decades because of increases in aging population and continued advances in cancer therapy with improved survival times across multiple cancer subtypes. Metastases to the vertebral column are found in up to 70% of cancer patients, with 10% of patients demonstrating epidural spinal cord compression. Therefore, many cancer patients may face spinal surgical intervention at some point of their chronic illness. Numerous surgical treatment options are currently available, ranging from simple cement augmentation over decompression of neural elements to extended instrumentation or reconstruction of the spine, including hybrid procedures that combine these techniques. However, precise surgical treatment guidelines do not exist, likely due to the absence of robust, long-term clinical outcomes data in these patients, and the overall heterogeneous nature of spinal tumors. The primary goal of Swiss-STR is to inform on the effectiveness of current practice in spinal oncology and its impact on patient outcomes. Furthermore, it will help to better categorize the different clinical presentations of spinal tumors, thereby facilitating treatment recommendations, assessing the socio-economic burden of this condition to the healthcare system, and improving the quality of care. In cases of rare tumors, multicenter data pooling will fill significant data gaps, allowing a better understanding of these entities. Finally, the approach is to first build and implement a high-quality registry with efficient electronic data capture strategies across hospital sites in Switzerland, with the potential to later expand internationally, providing opportunities for future international scientific collaboration to push the envelope in cancer research further.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Swiss-STR Cohort | – | –Patients with primary or metastatic spinal tumors undergoing surgical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients suffering from primary or metastatic spinal tumors, undergoing surgery
Key inclusion criteria (4 listed)
- Diagnosis of primary spinal tumor
- Diagnosis of secondary (metastatic) spinal tumor
- Indication for surgical treatment is present
- Patient age: =/>18 years
Key exclusion criteria (3 listed)
- Withdrawal of consent
- Withdrawal from initially planned surgical procedure
- Patient age: <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional Outcome as assessed by Karnofsky Performance Status Scale
Time frame: Through study completion, an average of 1 year
Rating in 10% steps * 100 Normal no complaints; no evidence of disease. * 90 Able to carry on normal activity; minor signs or symptoms of disease. * 80 Normal activity with effort; some signs or symptoms of disease. * 70 Cares for self; unable to carry on normal activity or to do active work. * 60 Requires occasional assistance, but is able to care for most of his personal needs. * 50 Requires considerable assistance and frequent medical care. * 40 Disabled; requires special care and assistance. * 30 Severely disabled; hospital admission is indicated although death is not imminent. * 20 Very sick; hospital admission necessary; active supportive treatment necessary. * 10 Moribund; fatal processes progressing rapidly. * 0 Dead
Physical performance assessed by the Timed-Up-and-Go-Test (TUG)
Time frame: Through study completion, an average of 1 year
Timed-Up-and-Go-Test in seconds
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Results publication: PubMed 37576924Nevzati E, Poletti N, Spiessberger A, Babler S, Studer G, Riklin C, Diebold J, Chatain GP, Finn M, Witt JP, Moser M, Mariani L. Establishing the Swiss Spinal Tumor Registry (Swiss-STR): a prospective observation of surgical treatment patterns and long-term outcomes in patients with primary and metastatic spinal tumors. Front Surg. 2023 Jul 28;10:1222595. doi: 10.3389/fsurg.2023.1222595. eCollection 2023.
- Individual participant dataSharing planned: Yes. All collected IPD
Related trials for Spinal Tumors
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
RecruitingObservational study
Evaluation and Treatment of Neurosurgical Disorders
Neurologic Disorders
Active, not recruitingPhase 3
Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy
Melanoma, Ovarian Cancer
RecruitingPhase 3
A Study to Learn About the Investigational Drug Rinzimetostat (ORIC-944) in Patients With mCRPC Who Were Previously Treated With Abiraterone Acetate (Himalayas-1)
Metastatic Castration Resistant Prostate Cancer
Not yet recruitingPhase 4
Remimazolam vs Propofol for Motor and Somatosensory Evoked Potentials in Spinal Tumor Surgery
Spinal Cord Neoplasms, Spinal Neoplasms
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.
Edin Nevzati, MD principal investigator
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 Tumors and Surgical Treatment, run by Luzerner Kantonsspital 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 19 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edin Nevzati, MD (+41412054504, edin.nevzati@luks.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Outcome as assessed by Karnofsky Performance Status Scale (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06869746, which also lists 1 linked publication.
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 19 Mar 2025.