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

NCT ID: NCT01825161

Last Updated: 2022-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

454 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Secondary Malignant Neoplasm of Vertebral Column

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Orthopaedic Research Foundation

OTHER

Sponsor Role collaborator

AO Foundation, AO Spine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles G Fisher, MD

Role: PRINCIPAL_INVESTIGATOR

Vancouver General Hospital and the University of British Columbia

Locations

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Kansas University Medical Center

Kansas City, Kansas, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status

Sunnybrook Health Sciences Center

Toronto, Ontario, Canada

Site Status

University of Toronto Hospital

Toronto, Ontario, Canada

Site Status

Montreal General Hospital

Montreal, Quebec, Canada

Site Status

National Center for Spinal Disorders

Budapest, , Hungary

Site Status

Countries

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United States Canada Hungary

References

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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.

Reference Type DERIVED
PMID: 38832791 (View on PubMed)

Related Links

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http://www.oref.org

Orthopedic Research Foundation

Other Identifiers

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SPN-12-002

Identifier Type: -

Identifier Source: org_study_id

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