Swiss Spinal Tumor Registry (Swiss-STR)

NCT06869746 | Recruiting DMC

• 1 other identifier: Swiss-STR
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Tumors; Surgical Treatment

Keywords

Spinal Tumor; Spinal Metastasis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Swiss-STR Cohort

Patients with primary or metastatic spinal tumors undergoing surgical treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Luzerner Kantonsspital: lead

Study Sites (1)

Lucerne Cantonal Hospital

Lucerne, Canton of Lucerne, 6000, Switzerland

RECRUITING

Related Publications (1)

• 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.

  PMID: 37576924 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Edin Nevzati, MD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edin Nevzati, MD

CONTACT

+41412054504; edin.nevzati@luks.ch

Severin Rüssli, MD

CONTACT

+41412054555; severin.ruessli@luks.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: March 11, 2025
• Study Start: January 1, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2032
• Last Updated: March 19, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: February 2025 until expiration of collaboration (max. 10 years)
• Access Criteria: All facilities contributing to the Swiss-STR get access the IPD after request to a review board

Locations

CH (1)