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NCT Number: NCT01470105

Improving a Bayesian Model's Survival Estimates in Patients Needing Surgery for Bone Metastases

The goal of this study is to improve how we estimate survival of people with cancer that has spread to their bone. There have been previous attempts to estimate survival of people with cancer that spread to the bone, but they have not been accurate. This study will try to improve the way we estimate survival in people with cancer that has spread to their bone by looking to see if a physician assessment and a patient assessment of the health status can be blended to give a better estimate of survival than patients or doctors alone.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ≥ to 18 years of age
  • Diagnosed with a metastatic malignancy
  • histologically proven in oligometastatic disease or by clinical suspicion in widely metastatic disease
  • by conventional radiographs, cross sectional imaging and/or scintigraphy
  • Scheduled for an orthopaedic operative intervention for skeletal metastases at MSKCC or Montefiore Medical Center including, not limited to the following:
  • Resection
  • Intramedullary Fixation
  • Prophylactic fixation
  • Curettage and cementation
  • Internal fixation
  • Arthroplasty
  • Spine stabilization

Exclusion criteria

  • None

Treatment and study plan

blood sampling, the SF-36 questionnaire

Other

The patient be asked to fill out a questionnaire. The questionnaire asks about their quality of life and will take approximately 15 minutes to complete. It will be completed at a regularly scheduled clinic visit.

At the scheduled pre-operative testing, an extra sample of your blood (equal to about 4 teaspoons) will be collected for research tests. The research tests will measure levels of inflammation in your body. These tests are not part of routine care. A physical examination of the operative site will be done by the Orthopaedic Surgeon. The patient will complete the same questionnaire at the regularly scheduled three and six month follow-up visit

Primary outcomes

  1. serum inflammatory cytokines

    Time frame: 3 years

    Whether the addition of serum inflammatory cytokines improves the robustness of an existing, validated Bayesian Belief network trained to estimate survival in human patients with operative skeletal metastases.

Secondary outcomes

  1. chemokine analysis

    Time frame: 3 years

    Whether the addition of chemokine analysis improves the robustness of an existing, validated Bayesian Belief network trained to estimate survival in human patients with operative skeletal metastases.

  2. patient-reported SF-36 data

    Time frame: 3 years

    Whether the addition of and inclusion of patient-reported SF-36 data, improves the robustness of an existing, validated Bayesian Belief network trained to estimate survival in human patients with operative skeletal metastases.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Montefiore Medical Center

Registry information

Important dates

Study start
2011
Primary completion
2026
Study completion
2026
First posted
Nov 11, 2011
Registry last updated
Jan 7, 2026

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

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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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