Early-stage Detection of Liver Cancer by Proteins in Peripheral Blood

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Proteomics

    Diagnostic test

    Proteomic is performed on all blood samples.

Treatment groups

600 Participants
are divided into 3 treatment groups
Group A: Hepatocellular carcinoma group1 intervention
Group B: Benign liver lesions group1 intervention
Group C: Healthy people group1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
up to 2 years
2

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

Secondary outcomes

1

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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