Validation of Novel Predictive Score for Patients With Spinal Metastases
1 other identifier
observational
219
1 country
1
Brief Summary
The investigators are prospectively validating a prognostic clinical tool that uses a patient's modified Bauer grade, ambulatory status, and pre-operative serum albumin to predict survival, post-treatment morbidity, and functional outcomes in patients with metastatic disease involving the spine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2017
CompletedFirst Submitted
Initial submission to the registry
July 14, 2017
CompletedFirst Posted
Study publicly available on registry
July 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2022
CompletedMarch 2, 2022
March 1, 2022
3 years
July 14, 2017
March 1, 2022
Conditions
Outcome Measures
Primary Outcomes (5)
Survival
Mortality is documented using date of death in medical record
Up to 3 years
EuroQuol 5-Dimension (EQ5D) profile
Assessment of state of health and physical/mental function
Up to 3 years
Short-Form (SF)-12
Assessment of state of health and physical/mental function
Up to 3 years
Visual Analog Scale (VAS) for pain
Assessment of current level of pain
Up to 3 years
Patient-Reported Outcomes Measurement Information System (PROMIS)
Assessment of global health
Up to 3 years
Secondary Outcomes (1)
Post-treatment morbidity and readmissions
Up to 3 years
Study Arms (3)
Surgical
Patients treated surgically for spinal metastases
Non-operative
Patients treated non-operatively for spinal metastases
Expectant
Patients receiving no treatment for spinal metastases
Eligibility Criteria
Patients with spinal metastases
You may qualify if:
- ≥ 18 years of age
- Confirmed diagnosis of cancer with metastatic spread to the mobile spine or sacrum
- Able to consent for themselves at the time of the intake evaluation
- Speaks English
You may not qualify if:
- Primary bone tumors or leukemia
- Metastases to other visceral or skeletal locations, without involvement of the spine or sacrum
- History of prior spine surgery for metastatic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Related Publications (1)
Xiong GX, Collins JE, Ferrone ML, Schoenfeld AJ. Prospective comparison of one-year survival in patients treated operatively and nonoperatively for spinal metastatic disease: results of the prospective observational study of spinal metastasis treatment (POST). Spine J. 2023 Jan;23(1):14-17. doi: 10.1016/j.spinee.2022.02.004. Epub 2022 Feb 16. No abstract available.
PMID: 35181541DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Schoenfeld, MD
Brigham and Women's Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 14, 2017
First Posted
July 21, 2017
Study Start
July 1, 2017
Primary Completion
July 13, 2020
Study Completion
January 31, 2022
Last Updated
March 2, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share