NCT01825161

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
454

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2013

Longer than P75 for all trials

Geographic Reach
3 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 5, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

September 13, 2022

Status Verified

September 1, 2022

Enrollment Period

6.3 years

First QC Date

March 28, 2013

Last Update Submit

September 12, 2022

Conditions

Secondary Malignant Neoplasm of Vertebral Column

Outcome Measures

Primary Outcomes (1)

  • 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.

    0, 6, 12, 26, 52 and 104 weeks

Secondary Outcomes (4)

  • Change in Pain Numeric Rating Scale (NRS)

    0, 6, 12, 26, 52 and 104 weeks

  • Change in EuroQoL 5D (EQ-5D)

    0, 6, 12, 26, 52 and 104 weeks

  • Change in Short Form 36 version 2 (SF-36 v2)

    0, 6, 12, 26, 52 and 104 weeks

  • Change in International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)

    0, 6, 12, 26, 52 and 104 weeks

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with metastatic spine disease

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Sunnybrook Health Sciences Center

Toronto, Ontario, M4N 3M5, Canada

Location

University of Toronto Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

National Center for Spinal Disorders

Budapest, 1126, Hungary

Location

Related Publications (1)

  • Barzilai 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: 38832791DERIVED

Related Links

Study Officials

  • Charles G Fisher, MD

    Vancouver General Hospital and the University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2013

First Posted

April 5, 2013

Study Start

August 1, 2013

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

September 13, 2022

Record last verified: 2022-09

Locations

HU(1)US(5)CA(4)