Hepatocellular Carcinoma
Conditions
Keywords
Hepatocellular Carcinoma, Diagnosis
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTProteomics
Proteomic is performed on all blood samples.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
First Affiliated Hospital of Harbin Medical University
Zhongnan Hospital
First Affiliated Hospital of Wenzhou Medical University
Jinhua Municipal Central Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Anhui Provincial Hospital
Beijing Tsinghua Changgeng Hospital
Qilu Hospital of Shandong University
West China Hospital
The First Affiliated Hospital of Zhengzhou University
Third Affiliated Hospital of Xinjiang Medical University
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
First Affiliated Hospital Xi'an Jiaotong University
Wuhan TongJi Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Voluntarily sign informed consent. 2. Male or female, age equal to or greater than 18 years and less than 75 years. 3. Patients with liver cancer who have been diagnosed or suspected for the first time within 42 days prior to blood collection 4. 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. 5. Patients with histologically or cytological, radiographically confirmed hepatocellular carcinoma.
Exclusion criteria
1. Female subjects who are pregnant or breastfeeding. 2. Previous organ transplantation or non-autologous bone marrow or stem cell transplantation. 3. 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. 4. History of previous malignant tumors. 5. Having other malignant tumors or multiple primary tumors at the same time.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peripheral blood protein concentrations | 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. |
| An early diagnosis model of liver cancer | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence or absence of intrahepatic and extrahepatic metastases of liver cancer | up to 2 years | 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. |
Countries
China
Contacts
CONTACTWeilin Wang
CONTACTYuan Ding
PRINCIPAL_INVESTIGATORWeilin Wang
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
PRINCIPAL_INVESTIGATORYuan Ding
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
PRINCIPAL_INVESTIGATORZhongquan Sun
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Outcome results
None listed