Assessment of Frailty in Patients With Advanced Hepatocellular Cancers (FAC-L)
研究概览
地位
条件
详细说明
This study is primarily looking to see if it is feasible to assess frailty in patients with advanced hepatocellular cancer. It is also evaluating whether there may be any correlation between these assessments and toxicity of treatment and outcome.
The assessments include: Frailty score, nutritional assessment, comorbidity score and quality of life. In addition sarcopenia will be assessed measuring muscle mass from imaging performed as part of routine clinical care.
The assessments will be performed at baseline on entry into the study, at week 9 and week 18.
There is the option for patients to also donate a blood samples for research purposes.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Newcastle upon Tyne、英国、NE7 7DN
- Newcastle Upon Tyne Hospitals NHS Foundation Trust
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Patients with a diagnosis of hepatocellular cancer not suitable for curative treatment
- Seen by an oncologist or hepatologist for consideration of palliative treatment and a decision regarding management already made
- WHO Performance status 0-2
- Childs Pugh Score A or B
- Written informed consent
Exclusion Criteria:
N/A
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学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage patients consenting for assessment out of number of patients approached
大体时间：baseline
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Number of patients consenting for the study as a percentage of the number of patients approached about the study
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baseline
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Time taken to complete assessments
大体时间：Baseline, week 9 and week 18
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Time taken to completed assessments recorded by clinical trials officer
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Baseline, week 9 and week 18
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Frailty as a predictor of grade 3/4 toxicity
大体时间：Baseline, week 9 and week 18
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Frailty score at baseline and during study time predict for outcome
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Baseline, week 9 and week 18
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Muscle mass and timed get up and go as predictors of outcome
大体时间：Baseline, week 9 and week 18
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muscle mass as measured on routine CT scans and get up and go as measured in frailty score
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Baseline, week 9 and week 18
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其他结果措施
结果测量 |
大体时间 |
|---|---|
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Quality of Life - EORTC QCQ 30 and HCC18
大体时间：Baseline, week 9 and week 18
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Baseline, week 9 and week 18
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Biomarker assessment of frailty and associated factors
大体时间：Baseline, week 9 and week 18
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Baseline, week 9 and week 18
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合作者和调查者
调查人员
- 首席研究员：Elizabeth R Plummer, MD, MRCP, BA, DPhil、Newcastle Unversity
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.