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OpenTrials
Completed

NCT Number: NCT01643174

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

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?

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Charles Fisher

Vancouver, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. overall survival

    Time frame: Average of 10 years

Secondary outcomes

  1. local recurrence

    Time frame: Average of 10 years

Sponsors and collaborators

Lead sponsor

AO Foundation, AO Spine

Other

Registry information

Official study 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

Acronym: PT

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 18, 2012
Registry last updated
Jun 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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