Improving a Bayesian Model's Survival Estimates in Patients Needing Surgery for Bone Metastases
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Bone Metastases |
Other: blood sampling, the SF-36 questionnaire |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Improving a Bayesian Model's Survival Estimates in Patients Needing Surgery for Bone Metastases |
- serum inflammatory cytokines [ Time Frame: 3 years ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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
Blood
| Estimated Enrollment: | 440 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Potential subjects will be recruited by the Orthopaedic Service of the Department of Surgery.
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 including, not limited to the following:
- Resection
- Intramedullary Fixation
- Prophylactic fixation
- Curettage and cementation
- Internal fixation
- Arthroplasty
- Spine stabilization
Exclusion Criteria:
- None
Contacts and Locations| Contact: John Healey, MD | 212-639-7611 | |
| Contact: Patrick Boland, MD | 212-639-8684 |
| United States, Maryland | |
| Naval Medical Research Center | Recruiting |
| Bethesda, Maryland, United States, 20889 | |
| Contact: Jonathan Agner Forsberg, MD 301-319-9788 Jonathan.A.Forsberg@health.mil | |
| Principal Investigator: Jonathan Agner Forsberg, MD | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center 1275 York Avenue | Recruiting |
| New York, New York, United States, 10021 | |
| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01470105 History of Changes |
| Other Study ID Numbers: | 11-121 |
| Study First Received: | November 9, 2011 |
| Last Updated: | April 16, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
questionnaire 11-121 |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Neoplasms, Second Primary Bone Neoplasms Bone Marrow Diseases Neoplastic Processes Neoplasms |
Pathologic Processes Neoplasms by Site Bone Diseases Musculoskeletal Diseases Hematologic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013