Clinical trial NCT01825161: The Epidemiology, Process and Outcomes of Spine Oncology (EPOSO)
Official title: The Epidemiology, Process and Outcomes of Spine Oncology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Secondary Malignant Neoplasm of Vertebral Column
Lead sponsor: AO Foundation, AO Spine
Sponsor class: OTHER
Collaborators: name: Orthopaedic Research Foundation
First posted: 2013-04-05
Enrollment: 454
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with metastatic spine disease

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in Spine Cancer Outcomes Questionnaire (SCOQ)
timeFrame: 0, 6, 12, 26, 52 and 104 weeks
Secondary outcomes:
measure: Change in Pain Numeric Rating Scale (NRS)
timeFrame: 0, 6, 12, 26, 52 and 104 weeks
measure: Change in EuroQoL 5D (EQ-5D)
timeFrame: 0, 6, 12, 26, 52 and 104 weeks
measure: Change in Short Form 36 version 2 (SF-36 v2)
timeFrame: 0, 6, 12, 26, 52 and 104 weeks
measure: Change in International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
timeFrame: 0, 6, 12, 26, 52 and 104 weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Center
state: Ontario
city: Toronto
country: Canada
facility: University of Toronto Hospital
state: Ontario
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
city: Budapest
country: Hungary
facility: National Center for Spinal Disorders
Study officials:
affiliation: Vancouver General Hospital and the University of British Columbia
name: Charles G Fisher, MD
role: PRINCIPAL_INVESTIGATOR
References: