Early-stage Detection of Liver Cancer by Proteins in Peripheral Blood: a Multi-center, Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- An early diagnosis model of liver cancer
研究概览
简要总结
By collecting blood samples from liver cancer patients and healthy individuals, and comparing the blood protein profiles of the two, the biomarkers for early diagnosis and tissue traceability were identified to accurately establish an early diagnosis model for liver cancer and verify its efficacy.
详细描述
This study is a prospective study to establish an early diagnosis model for the diagnosis of liver cancer based on peripheral blood protein indexes and verify its efficacy.
The study was divided into two phases: model establishment and model validation. In the model establishment stage, blood samples from subjects with liver cancer and corresponding benign lesions and healthy subjects were prospectively collected, and in the model validation stage, blood samples from subjects with liver cancer and corresponding benign lesions and healthy subjects were included in multiple centers, and a single-blind setting (analyst blinding) was carried out. The diagnosis, follow-up treatment and follow-up of subjects with cancer and benign lesions follow the routine clinical diagnosis and treatment procedures of the research center, and are not affected by this study. Healthy subjects undergo clinical examination in healthy persons according to the protocol of this study. The follow-up diagnosis, treatment and follow-up of subjects judged to be cancer, suspected cancer, benign lesions, and suspected benign lesions during the clinical examination will follow the routine clinical diagnosis and treatment procedures of the research center, and will not be affected by this study. This study is expected to enroll 600 subjects, including 300 subjects with liver cancer, 150 subjects with benign diseases, and 150 healthy subjects. The study is divided into two phases, and the first phase of the study will enroll 200 subjects at the Second Affiliated Hospital of Zhejiang University School of Medicine, including 100 subjects with liver cancer, 50 subjects with benign disease, and 50 healthy subjects. The second phase of the study will enroll 100 subjects at each center, including 50 cancer subjects, 25 benign disease subjects, and 25 healthy subjects.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Voluntarily sign informed consent.
- •Male or female, age equal to or greater than 18 years and less than 75 years.
- •Patients with liver cancer who have been diagnosed or suspected for the first time within 42 days prior to blood collection
- •The subject has not undergone any local or systemic anti-tumor therapy before blood collection, including (but not limited to) tumor surgical treatment for any purpose, local or systemic chemoradiotherapy, targeted therapy (including anti-angiogenic drugs), immunotherapy, cancer vaccine and hormone therapy, etc.
- •Patients with histologically or cytological, radiographically confirmed hepatocellular carcinoma.
排除标准
- •Female subjects who are pregnant or breastfeeding.
- •Previous organ transplantation or non-autologous bone marrow or stem cell transplantation.
- •Received drugs with anti-tumor effects for other diseases within 30 days before blood collection, such as drugs used for the treatment of immunorheumatic diseases such as methotrexate, cyclophosphamide, thiazoprine, chlorambucil, etc., drugs for the treatment of breast diseases, such as tamoxifen, etc.
- •History of previous malignant tumors.
- •Having other malignant tumors or multiple primary tumors at the same time.
结局指标
主要结局
An early diagnosis model of liver cancer
时间窗: up to 2 years
The sensitivity and specificity of an early diagnosis model for the diagnosis of liver cancer based on peripheral blood protein indexes and the accuracy of tissue traceability were established and verified.
Peripheral blood protein concentrations
时间窗: up to 2 years
The blood of liver cancer patients before treatment and the blood of non-liver cancer subjects were collected, and the differences between the peripheral blood protein characteristics of the above groups and those of non-liver cancer subjects and the blood protein characteristics that can be used for tissue traceability were analyzed. Peripheral blood protein concentrations were quantitatively measured by proteomic methods. Univariate COX regression method will be used to analyze whether the differences between the two groups are related to the diagnosis of liver cancer.
次要结局
- Presence or absence of intrahepatic and extrahepatic metastases of liver cancer(up to 2 years)