Predictors of Mortality and Morbidity in the Surgical Management of Primary Tumors of the Spine (PT)
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| ClinicalTrials.gov Identifier: NCT01643174 |
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Recruitment Status :
Completed
First Posted : July 18, 2012
Last Update Posted : June 20, 2013
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| Condition or disease |
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| Spine Tumor |
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 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 |
| Group/Cohort |
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| Surgical treatment |
- overall survival [ Time Frame: Average of 10 years ]
- local recurrence [ Time Frame: Average of 10 years ]
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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 |
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
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
| Canada | |
| Charles Fisher | |
| Vancouver, Canada | |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |