The Epidemiology, Process and Outcomes of Spine Oncology (EPOSO)

AO Foundation, AO Spine

Status: Completed

Conditions: Secondary Malignant Neoplasm of Vertebral Column

Study type: Observational

Funder types: Other

Identifiers

NCT01825161

SPN-12-002

Details and patient eligibility

About

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.

Enrollment: 454 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)