Improving a Bayesian Model's Survival Estimates in Patients Needing Surgery for Bone Metastases
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|ClinicalTrials.gov Identifier: NCT01470105|
Recruitment Status : Recruiting
First Posted : November 11, 2011
Last Update Posted : February 1, 2018
|Condition or disease||Intervention/treatment|
|Bone Metastases||Other: blood sampling, the SF-36 questionnaire|
|Study Type :||Observational|
|Estimated Enrollment :||230 participants|
|Official Title:||Improving a Bayesian Model's Survival Estimates in Patients Needing Surgery for Bone Metastases|
|Study Start Date :||November 2011|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2018|
pts bone metastases
This is a prospective, cross sectional, human use study conducted using patients with bone metastases requiring orthopaedic stabilization. Though this is an observational study, blood sampling, the SF-36 questionnaire, and ECOG performance status, and correlative studies will be performed.
Other: blood 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
- 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.
- 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.
- 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.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01470105
|Contact: John Healey, MD||212-639-7611|
|Contact: Patrick Boland, MD||212-639-8684|
|United States, New York|
|Montefiore Medical Center||Not yet recruiting|
|Bronx, New York, United States, 10467|
|Contact: Rui Yang, MD|
|Principal Investigator: Rui Yank, MD|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: John Healey, MD 212-639-7611|
|Contact: Patrick Boland, MD 212-639-8684|
|Principal Investigator: John Healey, MD|
|Principal Investigator:||John Healey, MD||Memorial Sloan Kettering Cancer Center|