跳至主要内容
临床试验/NCT01470105
NCT01470105进行中(未招募)不适用

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

Memorial Sloan Kettering Cancer Center3 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2011年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
230
试验地点
3
主要终点
serum inflammatory cytokines

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥ 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

排除标准

  • 未提供

研究组 & 干预措施

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.

干预措施: blood sampling, the SF-36 questionnaire (Other)

结局指标

主要结局

serum inflammatory cytokines

时间窗: 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.

次要结局

  • patient-reported SF-36 data(3 years)
  • chemokine analysis(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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