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.
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.
Study Type
OBSERVATIONAL
Enrollment
600
Proteomic is performed on all blood samples.
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGPeripheral blood protein concentrations
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.
Time frame: up to 2 years
An early diagnosis model of liver cancer
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.
Time frame: up to 2 years
Presence or absence of intrahepatic and extrahepatic metastases of liver cancer
The number and size of intrahepatic and extrahepatic metastases of liver cancer were measured by imaging methods to evaluate whether they were associated with the high risk predicted by the diagnostic model of liver cancer.
Time frame: up to 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.