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Predictors of Mortality and Morbidity in the Surgical Management of Primary Tumors of the Spine (PT)

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ClinicalTrials.gov Identifier: NCT01643174
Recruitment Status : Completed
First Posted : July 18, 2012
Last Update Posted : June 20, 2013
Sponsor:
Information provided by (Responsible Party):
AOSpine International

Study Description
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Brief Summary:
Within defined groups of primary malignant and benign bone and soft tissue spine tumors, what variables (clinical, diagnostic, therapeutic, and/or demographic) are associated with overall survival?

Condition or disease
Spine Tumor

Detailed Description:

Primary tumors of the spine are exceedingly rare and therefore the literature has been limited to case series of limited size and significant heterogeneity. These tumors comprise 11% of all Primary Musculoskeletal Tumors and 4.2% of all spine tumors. Of all primary spine tumors only 6% are malignant, but it is the malignant tumors that present the greatest therapeutic challenges. Through this multi-center retrospective cohort study performed at 13 spine oncology referral, data on at least 2.000 patients with specific primary benign and malignant spine tumors will be collected. This will provide power to determine the influence of many previously hypothesized variables on outcome.

The purpose of this study is to determine clinical, imaging and treatment factors that influence patient survival, local recurrence rate, and peri-operative/post-operative morbidity. Most surgical options carry significant morbidity and consume vast resources. In contrast, there is emerging evidence that incomplete or oncologically inappropriate resection increases local recurrence rate and decreases overall survival. These data will be used to refine existing study questions regarding patient outcomes and to develop new study questions that will be assessed in the future using prospectively collected data.


Study Design
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Study Type : Observational
Actual Enrollment : 1600 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Predictors of Mortality and Morbidity in the Surgical Management of Primary Tumors of the Spine: A Multi-center Retrospective Cohort Study With a Cross-Sectional Survival Check
Study Start Date : February 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : May 2013
Groups and Cohorts
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Group/Cohort
Surgical treatment


Outcome Measures
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Primary Outcome Measures :
  1. overall survival [ Time Frame: Average of 10 years ]

Secondary Outcome Measures :
  1. local recurrence [ Time Frame: Average of 10 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Retrospective chart review and selection
Criteria

Inclusion Criteria:

  • Were admitted to one of the participating spine centers with a diagnosis of primary tumor of the spine and were treated surgically.
  • At least one follow-up detectable in the medical charts

Exclusion Criteria:

  • metastatic tumor of the spine
  • primary spinal cord tumor
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01643174


Locations
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Canada
Charles Fisher
Vancouver, Canada
Sponsors and Collaborators
AOSpine International
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AOSpine International
ClinicalTrials.gov Identifier: NCT01643174     History of Changes
Other Study ID Numbers: PT retro
First Posted: July 18, 2012    Key Record Dates
Last Update Posted: June 20, 2013
Last Verified: June 2013