About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Male or female, aged 18 years or older, less than 75 years of age and people who voluntarily sign informed consent
Trial design
Cohort
Prospective
Treatments tested in this trial
Proteomics
Diagnostic testProteomic is performed on all blood samples.
Treatment groups
Trial outcomes
Primary outcomes
Peripheral 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.
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.
Secondary outcomes
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.
Sponsors and contacts
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Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead sponsor
First Affiliated Hospital of Harbin Medical University
Collaborator
Zhongnan Hospital
Collaborator
First Affiliated Hospital of Wenzhou Medical University
Collaborator
Jinhua Municipal Central Hospital
Collaborator
Third Affiliated Hospital, Sun Yat-Sen University
Collaborator
Anhui Provincial Hospital
Collaborator
Beijing Tsinghua Changgeng Hospital
Collaborator
Qilu Hospital of Shandong University
Collaborator
West China Hospital
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Third Affiliated Hospital of Xinjiang Medical University
Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
Wuhan TongJi Hospital
Collaborator