Liver CAncer PRognosis InvEstigation Study (Liver-CARE)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Death
研究概览
简要总结
This prospective cohort study is designed to explore the role of environmental, clinical, and genetic risk factors in the progression and prognosis of primary liver cancer (PLC). We will recruit 5000 patients with newly diagnosed, previously untreated PLC. The eligible patients will be asked to complete a baseline survey at the time of initial admission and be followed up every 3 to 6 months after discharge.
详细描述
Primary liver cancer (PLC) is highly malignant and is particularly prevalent in China. Multiple factors are involved in the development and progression of PLC. Several large-scale, prospective cohort studies have been established to identify environmental and genetic risk factors for the development of PLC in the general population. However, few cohort studies have focused on determining risk factors beyond clinical prognostic factors for the progression of PLC in patients with PLC. Therefore, we will conduct a prospective cohort study to examine the role of environmental, clinical, and genetic risk factors in the progression and prognosis of PLC. We plan to recruit 5000 patients with newly diagnosed, previously untreated PLC. A baseline survey will be conducted at the time of initial admission, with follow-up at 3 and 6 months after discharge for all patients and thereafter every 3 months for patients treated with interventional therapy and every 6 months for patients receiving surgery and other therapies. We will collect information on patients' demographics characteristics, clinical diagnosis and treatment, lifestyle, nutritional status, psychological and mental status, quality of life, anthropometric data, body composition, routine laboratory tests and examinations, and disease progression through structured questionnaires, physical examinations, and medical record reviews. Deaths will be ascertained through medical records, death certificates, and next-of-kin. Additionally, we will collect blood, urine, stool, and liver tissue samples.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years,
- •Diagnosed with primary liver cancer (ICD-10: C22) (Referring to the diagnostic criteria in the "Primary Liver Cancer Diagnosis and Treatment Guidelines (2024 Edition)" and the "2024 CSCO Guidelines for the Diagnosis and Treatment of Biliary Malignancies),
- •Have not received any anti-tumor treatment (e.g., surgery, ablation, interventional therapy, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc),
- •Signed informed consent.
排除标准
- •Have a history of other malignant tumors,
- •Have a history of other serious chronic diseases (e.g., heart failure, liver failure, kidney failure, etc.),
- •Expected survival time is no more than 3 months,
- •Severe physical or mental disability.
结局指标
主要结局
Death
时间窗: Up to 20 years
The primary endpoint of this study is all-cause mortality and liver caner-specific mortality. The exact death time and the cause of death of each participant will be checked in the government medical records system.
次要结局
- Recurrence (intrahepatic and extrahepatic)(From date of diagnosis until the date of cancer recurrence or date of death from any cause, whichever came first, assessed up to 20 years)
- Newly Emerging Diseases(From date of diagnosis until the date of newly emerging diseases or date of death from any cause, whichever came first, assessed up to 20 years)
- Response Evaluation(through study period, every 3-6 months)
- Nutritional status(through study period, every 3-6 months)
- Quality of life(through study period, every 3-6 months)
- Psychological and mental status(through study period, every 3-6 months)
- Cachexia assessment(through study period, every 3-6 months)
- Sarcopenia(through study period, every 3-6 months)
- Frailty(through study period, every 3-6 months)
研究者
Aiping Fang
Associate Professor
Sun Yat-sen University