INSYNC: Leo Jenkins Cancer Center (LJCC) - Symptom Management Service (SMS) Protocol -Phase II Trial Regarding The Effect Of Comprehensive Symptom Management On Inflammation And Survival In Metastatic Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
There is a growing body of evidence that implicates inflammation as a mechanism of disease progression and reduced survival in patients with advanced cancer. Elevated c-reactive protein levels have been shown to be associated with reduced performance status, specific cancer related symptoms and reduced overall survival. C-reactive protein levels are a surrogate for IL-6 expression. IL-6 is part of an inflammatory signature predicting cancer recurrence. VeriStrat® is a multivariate test which measures protein expression related to a host/tumor interaction mediated by inflammation. The investigators hope to examine the relationship between quality of life outcomes per FACT-L survey and correlate them with changes in c-reactive protein levels and the VeriStrat® status. The hypothesis of this study is that the remarkable survival benefit in the Temel study is mediated by reduced inflammation with improvement of symptom control.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 否
入选标准
- •Confirmed diagnosis of stage IV non-small cell lung cancer
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •Able to read and respond to questions in English
排除标准
- •Small Cell Lung Cancer
结局指标
主要结局
Overall Survival
时间窗: Patients will be followed for 5 years after enrolling last patient
Overall survival from diagnosis until death from any cause
次要结局
- Percentage of patients who convert from c-reactive protein 'high' (> 10 mg/L) to 'low' (<10 mg/L)(10 months)
- Change in VeriStrat status(10 months)
- Quality of Life (QOL) indicators per FACT-L score and the following at baseline, 4 months and 10 months groups(10 months)