Swiss Spinal Tumor Registry (Swiss-STR) (SSTR)

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.

Study Overview

• Status: Recruiting
• Conditions: Surgical Treatment; Spinal Tumors

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 Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Edin Nevzati, MD; Phone Number: +41412054504; Email: edin.nevzati@luks.ch
• Study Contact Backup: Name: Severin Rüssli, MD; Phone Number: +41412054555; Email: severin.ruessli@luks.ch

Study Locations

• Switzerland
  • Lucerne, Switzerland, 6000
    • Recruiting
    • Lucerne Cantonal Hospital
    • Contact: Sabrina Bäbler, MD; Phone Number: +41412051624; Email: sabrina.bäbler@luks.ch
    • Contact: Severin Rüssli, MD
    • Contact: Severin Rüssli, MD; Phone Number: +41412054555; Email: severin.ruessli@luks.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients suffering from primary or metastatic spinal tumors, undergoing surgery

Description

Inclusion Criteria:

• Diagnosis of primary spinal tumor
• Diagnosis of secondary (metastatic) spinal tumor
• Indication for surgical treatment is present
• Patient age: =/>18 years

Exclusion criteria:

• Withdrawal of consent
• Withdrawal from initially planned surgical procedure
• Patient age: <18 years

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Swiss-STR Cohort; Patients with primary or metastatic spinal tumors undergoing surgical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Luzerner Kantonsspital
• Investigators: Principal Investigator: Edin Nevzati, MD

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: February 3, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 14, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Spinal Metastasis; Spinal Tumor
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Bone Neoplasms; Spinal Diseases; Nervous System Neoplasms; Central Nervous System Neoplasms; Spinal Cord Diseases; Spinal Cord Neoplasms; Spinal Neoplasms
• Other Study ID Numbers: Swiss-STR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected IPD
• IPD Sharing Time Frame: February 2025 until expiration of collaboration (max. 10 years)
• IPD Sharing Access Criteria: All facilities contributing to the Swiss-STR get access the IPD after request to a review board
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No