Bone Metastases
Conditions
Keywords
questionnaire, 11-121
Brief summary
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.
Interventions
OTHERblood sampling, the SF-36 questionnaire
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
Sponsors
Montefiore Medical Center
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| serum inflammatory cytokines | 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
| Measure | Time frame | Description |
|---|---|---|
| chemokine analysis | 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. |
| patient-reported SF-36 data | 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. |
Countries
United States
Outcome results
None listed