Clinical trial · Observational
The Epidemiology, Process and Outcomes of Spine Oncology (EPOSO)
The Epidemiology, Process and Outcomes of Spine Oncology
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main purpose of this study is to utilize a comprehensive, prospective clinical database to collect patient, diagnostic and treatment variables along with disease specific and generic health related quality of life (HRQOL) data on consecutively treated patients with metastatic spine tumors. The objectives are to determine the validity and reliability of the Spine Cancer Outcomes Questionnaire (SCOQ) for use in the assessment of spine tumor outcomes, to determine if the Spine Instability Neoplastic Score (SINS) Classification is a valid tool for predicting the stability of spine in metastatic spine disease, and to determine the efficacy of surgery versus radiotherapy for the treatment of impending instability secondary to metastatic disease of the spine.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Secondary Malignant Neoplasm of Vertebral Column | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Change in Spine Cancer Outcomes Questionnaire (SCOQ)
- timeFrame
- 0, 6, 12, 26, 52 and 104 weeks
- description
- This is a new questionnaire, also referred to as the Spine Oncology Self-Assessment, developed by members of the SOSG. It is made up of 5 domains: physical function, neural function, pain, mental health and social function. It was developed as a comparison to the SF-36 for patients with spine tumors. The reliability and validity of this questionnaire will be compared with the SF-36v2.
Secondary outcomes (4)
- measure
- Change in Pain Numeric Rating Scale (NRS)
- timeFrame
- 0, 6, 12, 26, 52 and 104 weeks
- description
- The Pain NRS is an 11-point horizontal scale where the end points are the extremes of no pain (0) and pain as bad as it could be, or worst pain (10). It measures subjective intensity of pain and the patient rates his/her overall or average daily pain.
- measure
- Change in EuroQoL 5D (EQ-5D)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent * Age between 18 and 75 years * Able to read and write English at an elementary level * Diagnosis of metastatic tumor of the spine Exclusion Criteria: * The primary cancer site is central nervous system or spine * History of substance abuse (recreational drugs, alcohol) within 12 months prior to screening * Is a prisoner * A disease or condition that would, in opinion of the investigator, preclude accurate evaluation (e.g. significant psychiatric disease)
References
Publications (2)
- DERIVEDVersteeg AL, Sahgal A, Laufer I, Rhines LD, Sciubba DM, Schuster JM, Weber MH, Lazary A, Boriani S, Bettegowda C, Fehlings MG, Clarke MJ, Arnold PM, Gokaslan ZL, Barzilai O, Dea N, Gasbarrini A, Netzer C, Reynolds JJ, Verlaan JJ, Fisher CG; AO Spine Knowledge Forum tumor. Minimal clinically important differences in the Spine Oncology Study Group Outcomes Questionnaire (SOSGOQ2.0) in patients with symptomatic spinal metastases. Spine J. 2026 Oct;26(10):1977-1984. doi: 10.1016/j.spinee.2026.05.007. Epub 2026 Jun 10. PMID 42269936
- DERIVEDBarzilai O, Sahgal A, Rhines LD, Versteeg AL, Sciubba DM, Lazary A, Weber MH, Schuster JM, Boriani S, Bettegowda C, Arnold PM, Clarke MJ, Laufer I, Fehlings MG, Gokaslan ZL, Fisher CG; AO Spine Knowledge Forum Tumor. Patient-Reported and Clinical Outcomes of Surgically Treated Patients With Symptomatic Spinal Metastases: Results From Epidemiology, Process, and Outcomes of Spine Oncology (EPOSO), a Prospective, Multi-Institutional and International Study. Neurosurgery. 2024 Nov 1;95(5):1148-1157. doi: 10.1227/neu.0000000000002989. Epub 2024 Jun 4. PMID 38832791