Clinical trial NCT06869746: Swiss Spinal Tumor Registry (Swiss-STR)
Official title: Swiss Spinal Tumor Registry (Swiss-STR)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Tumors
Surgical Treatment
Keywords: Spinal Tumor
Spinal Metastasis
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients suffering from primary or metastatic spinal tumors, undergoing surgery

Brief 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.

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.

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

Primary outcomes:
measure: Functional Outcome as assessed by Karnofsky Performance Status Scale
timeFrame: Through study completion, an average of 1 year
measure: Physical performance assessed by the Timed-Up-and-Go-Test (TUG)
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Lucerne
country: Switzerland
facility: Lucerne Cantonal Hospital
Study officials:
name: Edin Nevzati, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.