Validation of Novel Predictive Score for Patients With Spinal Metastases

Spinal Metastases Clinical Trial

Official title:

Validation of Novel Predictive Score for Patients With Spinal Metastases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03224650
• Other study ID #: 2017P000203
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Spinal Metastases

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