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OpenTrials
Completed

NCT Number: NCT03224650

Validation of Novel Predictive Score for Patients With Spinal Metastases

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Survival

    Time frame: Up to 3 years

    Mortality is documented using date of death in medical record

  2. EuroQuol 5-Dimension (EQ5D) profile

    Time frame: Up to 3 years

    Assessment of state of health and physical/mental function

  3. Short-Form (SF)-12

    Time frame: Up to 3 years

    Assessment of state of health and physical/mental function

  4. Visual Analog Scale (VAS) for pain

    Time frame: Up to 3 years

    Assessment of current level of pain

  5. Patient-Reported Outcomes Measurement Information System (PROMIS)

    Time frame: Up to 3 years

    Assessment of global health

Secondary outcomes

  1. Post-treatment morbidity and readmissions

    Time frame: Up to 3 years

    Post treatment complications and readmissions documented in medical record

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2022
First posted
Jul 21, 2017
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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