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

March 14, 2025 updated by: Luzerner Kantonsspital
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Swiss-STR Cohort
Patients with primary or metastatic spinal tumors undergoing surgical treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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
Timed-Up-and-Go-Test in seconds
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Luzerner Kantonsspital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Edin Nevzati, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Dietary Supplements

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