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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03224650
Other study ID # 2017P000203
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2017
Est. completion date January 31, 2022

Study information

Verified date March 2022
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 219
Est. completion date January 31, 2022
Est. primary completion date July 13, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. = 18 years of age 2. Confirmed diagnosis of cancer with metastatic spread to the mobile spine or sacrum 3. Able to consent for themselves at the time of the intake evaluation 4. Speaks English Exclusion Criteria: 5. Primary bone tumors or leukemia 6. Metastases to other visceral or skeletal locations, without involvement of the spine or sacrum 7. History of prior spine surgery for metastatic disease

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Survival Mortality is documented using date of death in medical record Up to 3 years
Primary EuroQuol 5-Dimension (EQ5D) profile Assessment of state of health and physical/mental function Up to 3 years
Primary Short-Form (SF)-12 Assessment of state of health and physical/mental function Up to 3 years
Primary Visual Analog Scale (VAS) for pain Assessment of current level of pain Up to 3 years
Primary Patient-Reported Outcomes Measurement Information System (PROMIS) Assessment of global health Up to 3 years
Secondary Post-treatment morbidity and readmissions Post treatment complications and readmissions documented in medical record Up to 3 years
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