Menu
Recruiting NCT06869746

Swiss Spinal Tumor Registry (Swiss-STR)

Observational Spinal Tumors Surgical Treatment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Spinal Tumors, Surgical Treatment. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Functional Outcome as assessed by Karnofsky Performance Status Scale [Time frame: Through study completion, an average of 1 year]
  • Physical performance assessed by the Timed-Up-and-Go-Test (TUG) [Time frame: Through study completion, an average of 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Switzerland · 1 center
  • Lucerne Cantonal Hospital — Lucerne

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. eCollectio PMID 37576924

Identifiers

NCT: NCT06869746 · Swiss-STR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗