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Validation of Novel Predictive Score for Patients With Spinal Metastases

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03224650
Collaborator
(none)
219
Enrollment
1
Location
55
Actual Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    219 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Validation of Novel Predictive Score for Patients With Spinal Metastases
    Actual Study Start Date :
    Jul 1, 2017
    Actual Primary Completion Date :
    Jul 13, 2020
    Actual Study Completion Date :
    Jan 31, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Surgical

    Patients treated surgically for spinal metastases
    Non-operative

    Patients treated non-operatively for spinal metastases
    Expectant

    Patients receiving no treatment for spinal metastases

    Outcome Measures

    Primary Outcome Measures

    1. Survival [Up to 3 years]

      Mortality is documented using date of death in medical record

    2. EuroQuol 5-Dimension (EQ5D) profile [Up to 3 years]

      Assessment of state of health and physical/mental function

    3. Short-Form (SF)-12 [Up to 3 years]

      Assessment of state of health and physical/mental function

    4. Visual Analog Scale (VAS) for pain [Up to 3 years]

      Assessment of current level of pain

    5. Patient-Reported Outcomes Measurement Information System (PROMIS) [Up to 3 years]

      Assessment of global health

    Secondary Outcome Measures

    1. Post-treatment morbidity and readmissions [Up to 3 years]

      Post treatment complications and readmissions documented in medical record

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    1. Primary bone tumors or leukemia

    2. Metastases to other visceral or skeletal locations, without involvement of the spine or sacrum

    3. History of prior spine surgery for metastatic disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Brigham and Women's Hospital Boston Massachusetts United States 02115

    Sponsors and Collaborators

    • Brigham and Women's Hospital

    Investigators

    • Principal Investigator: Andrew Schoenfeld, MD, Brigham and Women's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andrew Schoenfeld, Associate Professor, Brigham and Women's Hospital
    ClinicalTrials.gov Identifier:
    NCT03224650
    Other Study ID Numbers:
    • 2017P000203
    First Posted:
    Jul 21, 2017
    Last Update Posted:
    Mar 2, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasm Metastasis

    Study Results

    No Results Posted as of Mar 2, 2022