Completed

EPOSOThe Epidemiology, Process and Outcomes of Spine Oncology

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

From 18 to 75 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: August 2013
See protocol details

Summary

Principal SponsorAO Foundation, AO Spine
Last updated: September 13, 2022
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01825161
Principal SponsorAO Foundation, AO Spine
Last updated: September 13, 2022
Sourced from a government-validated database.Claim as a partner

Protocol

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

454 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
Able to read and write English at an elementary level
Age between 18 and 75 years
Diagnosis of metastatic tumor of the spine
Signed informed consent
4 exclusion criteria prevent from participating
A disease or condition that would, in opinion of the investigator, preclude accurate evaluation (e.g. significant psychiatric disease)
History of substance abuse (recreational drugs, alcohol) within 12 months prior to screening
Is a prisoner
The primary cancer site is central nervous system or spine

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 10 locations

Kansas University Medical Center

Kansas City, United StatesOpen Kansas University Medical Center in Google Maps

Johns Hopkins University

Baltimore, United States

Mayo Clinic

Rochester, United States

Hospital of the University of Pennsylvania

Philadelphia, United States
Completed10 Study Centers