Spinal MetastasesNCT03224650
Validation of Novel Predictive Score for Patients With Spinal Metastases
An observational study of Spinal Metastases, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Metastases
- How many people
- 219 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 31 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with spinal metastases
Who may be able to join
- ≥ 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the detailed description
Recently, the investigators proposed a clinical prediction score that used a patient's modified Bauer grade, ambulatory status, and pre-operative serum albumin as a means to predict long-term survival following spine surgery for metastatic disease. This prognostic utility was developed using one-year mortality as the sole outcome measure. While the scoring system demonstrated many of the necessary attributes of a useful prediction tool, including simplicity, ease of use and clinical utility, it has yet to be validated prospectively and its capacity to predict other peri-operative outcomes, including physical and mental function following intervention, pain relief and the risk of complications, remain incompletely explored. To further evaluate the utility of this prognostic score, the investigators propose a series of three integrated experiments that will prospectively determine its capacity to accurately inform clinical decision making and recommendations for surgery for patients with metastatic spinal disease.
- Conditions
- Spinal Metastases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Surgical | Patients treated surgically for spinal metastases | |
| Non-operative | Patients treated non-operatively for spinal metastases | |
| Expectant | Patients receiving no treatment for spinal metastases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Mortality is documented using date of death in medical record
Measured: Up to 3 years
EuroQuol 5-Dimension (EQ5D) profile
Assessment of state of health and physical/mental function
Measured: Up to 3 years
Short-Form (SF)-12
Assessment of state of health and physical/mental function
Measured: Up to 3 years
Visual Analog Scale (VAS) for pain
Assessment of current level of pain
Measured: Up to 3 years
Patient-Reported Outcomes Measurement Information System (PROMIS)
Assessment of global health
Measured: Up to 3 years
Secondary outcomes (1)
Post-treatment morbidity and readmissions
Post treatment complications and readmissions documented in medical record
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start1 Jul 2017
- Primary completion13 Jul 2020
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal MetastasesStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Schoenfeld, Brigham and Women's Hospital
- Investigators
- Andrew Schoenfeld, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224650
- Sponsor's protocol ID
- 2017P000203
- Status last verified
- Mar 2022
- First submitted
- 14 Jul 2017
- Last updated
- 2 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35181541
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Novel Predictive Score for Patients With Spinal Metastases
- ClinicalTrials.gov ID
- NCT03224650
- Acronym / sponsor ID
- 2017P000203
- Conditions
- Spinal Metastases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 13 Jul 2020 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Recently, the investigators proposed a clinical prediction score that used a patient's modified Bauer grade, ambulatory status, and pre-operative serum albumin as a means to predict long-term survival following spine surgery for metastatic disease. This prognostic utility was developed using one-year mortality as the sole outcome measure. While the scoring system demonstrated many of the necessary attributes of a useful prediction tool, including simplicity, ease of use and clinical utility, it has yet to be validated prospectively and its capacity to predict other peri-operative outcomes, including physical and mental function following intervention, pain relief and the risk of complications, remain incompletely explored. To further evaluate the utility of this prognostic score, the investigators propose a series of three integrated experiments that will prospectively determine its capacity to accurately inform clinical decision making and recommendations for surgery for patients with metastatic spinal disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Surgical | – | –Patients treated surgically for spinal metastases |
| Non-operative | – | –Patients treated non-operatively for spinal metastases |
| Expectant | – | –Patients receiving no treatment for spinal metastases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with spinal metastases
Key inclusion criteria (4 listed)
- ≥ 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival
Time frame: Up to 3 years
Mortality is documented using date of death in medical record
EuroQuol 5-Dimension (EQ5D) profile
Time frame: Up to 3 years
Assessment of state of health and physical/mental function
Short-Form (SF)-12
Time frame: Up to 3 years
Assessment of state of health and physical/mental function
Visual Analog Scale (VAS) for pain
Time frame: Up to 3 years
Assessment of current level of pain
Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: Up to 3 years
Assessment of global health
1 secondary outcome
Post-treatment morbidity and readmissions
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Derived from this study: PubMed 35181541Xiong 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Schoenfeld, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Metastases, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: Up to 3 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03224650, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.