NCT02011815已完成不适用
A Prospective Study of Exploring Possible Biological Linkage Between Circadian Disruption and Cancer Progression
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
The purpose of this study is to explore the possible association between the circadian disruption and cancer progression.
详细描述
The biological markers that are assumed to bridge this association are measured and analyzed.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 18-70
- •Breast cancer patients who are getting chemotherapy for the first time in life
- •Patients are either having stage 4 cancer or starting neoadjuvant chemotherapy.
- •Patient have signed on the informed consent, and well understood the objective and procedure of this study
排除标准
- •Patients already have received chemotherapy
- •Patient had another cancer (except thyroid cancer) within 5 years
- •Patient with severe medical condition
- •Patient had taken psychiatric medication more than 1 month in life
- •Patient worked the night shift for more than 1 month in 6 months
结局指标
主要结局
Progression-free survival
时间窗: 3 years (and more) after recruitment
The data progression-free survival will be done by reviewing patients' medical record.
次要结局
- Objective sleep cycle measures(Baseline, after 1 month, after 6 month, after 12 month)
- Sleep quality measures(Baseline, after 1 month, after 6 month, after 12 month)
- Distress related measure(Baseline, after 1 month, after 6 month, after 12 month)
- Posttraumatic Stress-related symptom measure(Baseline, after 1 month, after 6 month, after 12 month)
- Genetic polymorphism(Baseline)
- Physiological measures(Baseline, after 1 month, after 6 month, after 12 month)
- Cortisol level(Baseline)
- Inflammatory markers(Baseline)
- Overall survival(3 years (and more) after recruitment)
- Quality of Life measure(Baseline, after 1 month, after 6 month, after 12 month)
- Cancer related Fatigue(Baseline, after 1 month, after 6 month, after 12 month)
- Menopausal symptom measure(Baseline, after 1 month, after 6 month, after 12 month)
- Epigenetic Change(Baseline)
- Circadian disruption(Baseline, after 1 month, after 6 month, after 12 month)
- Personality measure(Baseline)
- Melatonin(Baseline)
研究者
研究点 (1)
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