Predictors of Mortality and Morbidity in the Surgical Management of Primary Tumors of the Spine (PT)
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Purpose
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 |
|---|
|
Spine Tumor |
| Study Type: | Observational |
| Study Design: | 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 |
- overall survival [ Time Frame: Average of 10 years ] [ Designated as safety issue: No ]
- local recurrence [ Time Frame: Average of 10 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 2000 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Surgical treatment |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Retrospective chart review and selection
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| Contact: Peter Langer, PhD, MSc | 0041442002468 | planger@aospine.org |
| Canada | |
| Charles Fisher | Recruiting |
| Vancouver, Canada | |
| Contact: Charles Fisher, MD, MPH 6048754746 charles.fisher@vch.ca | |
| Principal Investigator: Charles Fisher, MD, MPH | |
More Information
No publications provided
| Responsible Party: | AOSpine International |
| ClinicalTrials.gov Identifier: | NCT01643174 History of Changes |
| Other Study ID Numbers: | PT retro |
| Study First Received: | April 17, 2012 |
| Last Updated: | July 16, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Spinal Cord Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site |
Neoplasms Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013