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

Active, not recruiting

• Conditions: Bone Metastases
• Interventions: Other: blood sampling, the SF-36 questionnaire

• Registration Number: NCT01470105
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-09
• Study First Submitted QC: 2011-11-09
• Study First Posted: 2011-11-11
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 230

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pts bone metastases	blood sampling, the SF-36 questionnaire	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (2)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States