Secondary Malignant Neoplasm of Vertebral ColumnEPOSONCT01825161
The Epidemiology, Process and Outcomes of Spine Oncology (EPOSO)
An observational study of Secondary Malignant Neoplasm of Vertebral Column, run by AO Foundation, AO Spine at 10 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Secondary Malignant Neoplasm of Vertebral Column
- How many people
- 454 participants
- Where
- 10 sitesin 3 countries
- Study dates
- Aug 2013to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic spine disease
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
United States5 sites
Johns Hopkins University
Baltimore, Maryland, 21218
MD Anderson Cancer Center
Houston, Texas, 77030
Kansas University Medical Center
Kansas City, Kansas, 66160
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55905
Canada4 sites
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Sunnybrook Health Sciences Center
Toronto, Ontario, M4N 3M5
University of Toronto Hospital
Toronto, Ontario, M5T 2S8
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: The Epidemiology, Process and Outcomes of Spine Oncology
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Spine Cancer Outcomes Questionnaire (SCOQ)
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.
Measured: 0, 6, 12, 26, 52 and 104 weeks
Secondary outcomes (4)
Change in Pain Numeric Rating Scale (NRS)
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.
Measured: 0, 6, 12, 26, 52 and 104 weeks
Change in EuroQoL 5D (EQ-5D)
The EuroQOL group developed a standardized instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments, it contains 5 questions and provides a simple descriptive profile and a single index value for health status. EQ-5D is designed for self-completion by respondents and is ideally suited for use in mailed surveys, in clinics and face-to-face interviews. It is cognitively simple, taking only a few minutes to complete. Instructions to respondents are included in the questionnaire.
Measured: 0, 6, 12, 26, 52 and 104 weeks
Change in Short Form 36 version 2 (SF-36 v2)
The SF-36 v2 (Medical Outcomes Trust, Boston, MA) is a multipurpose, short-form health survey with 36 questions available in several languages. It yields an eight-scale profile of scores: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. In addition, two composite scores are constructed using factorial modeling, one for physical health (Physical Composite Score - PCS) and one for mental health (Mental Composite Score - MCS).
Measured: 0, 6, 12, 26, 52 and 104 weeks
Change in International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
ISNCSCI is a standardized examination to determine neurologic function and has been a standard clinical assessment for patients with neurological deficit. The modified ISNCSCI used in this study will assess the Motor Score and the ASIA Impairment Scale V 1.3 only.
Measured: 0, 6, 12, 26, 52 and 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Secondary Malignant Neoplasm of Vertebral ColumnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 454 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Foundation, AO Spine
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopaedic Research Foundation
- Responsible party
- Sponsor
- Investigators
- Charles G Fisher, MD, Principal investigator, Vancouver General Hospital and the University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825161
- Sponsor's protocol ID
- SPN-12-002
- Acronym
- EPOSO
- Status last verified
- Sep 2022
- First submitted
- 28 Mar 2013
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Versteeg 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.
PubMed 42269936Barzilai 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.
PubMed 38832791
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Epidemiology, Process and Outcomes of Spine Oncology
- ClinicalTrials.gov ID
- NCT01825161
- Acronym / sponsor ID
- EPOSO / SPN-12-002
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 454 participants (actual)
- Lead sponsor
- AO Foundation, AO SpineUniversity, hospital or other
- Collaborators
- Orthopaedic Research Foundation
- Study start
- Aug 2013
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 5 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic spine disease
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Spine Cancer Outcomes Questionnaire (SCOQ)
Time frame: 0, 6, 12, 26, 52 and 104 weeks
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.
4 secondary outcomes
Change in Pain Numeric Rating Scale (NRS)
Time frame: 0, 6, 12, 26, 52 and 104 weeks
Change in EuroQoL 5D (EQ-5D)
Time frame: 0, 6, 12, 26, 52 and 104 weeks
Change in Short Form 36 version 2 (SF-36 v2)
Time frame: 0, 6, 12, 26, 52 and 104 weeks
Change in International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
Time frame: 0, 6, 12, 26, 52 and 104 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Derived from this study: PubMed 42269936Versteeg 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.
- Derived from this study: PubMed 38832791Barzilai 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.
- AOSpineLink provided by the sponsor.
- Orthopedic Research FoundationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles G Fisher, MD principal investigator
Vancouver General Hospital and the University of British Columbia
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Secondary Malignant Neoplasm of Vertebral Column, run by AO Foundation, AO Spine at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Spine Cancer Outcomes Questionnaire (SCOQ) (time frame: 0, 6, 12, 26, 52 and 104 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01825161, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.