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

Early-stage Detection of Liver Cancer by Proteins in Peripheral Blood: a Multi-center, Prospective Study

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Diagnostic test: Proteomics

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.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Weilin Wang; Phone Number: 13606642087; Email: wam@zju.edu.cn
• Study Contact Backup: Name: Yuan Ding; Phone Number: 18858101960; Email: dingyuan@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • 2nd Affiliated Hospital, School of Medicine, Zhejiang University
      • Contact: Weilin Wang; Phone Number: +86 13606642087; Email: wam@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Male or female, aged 18 years or older, less than 75 years of age and people who voluntarily sign informed consent

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hepatocellular carcinoma group; Patients with histologically or cytological, imaging confirmed untreated hepatocellular carcinoma.	Diagnostic test: Proteomics; Proteomic is performed on all blood samples.
Benign liver lesions group; Untreated patients with confirmed or suspected benign liver lesions by histopathology, or with high suspicion of benign liver lesions by imaging evaluation or other routine clinical diagnosis	Diagnostic test: Proteomics; Proteomic is performed on all blood samples.
Healthy people group; People without any liver disease	Diagnostic test: Proteomics; Proteomic is performed on all blood samples.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 2 years

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: West China Hospital; Qilu Hospital of Shandong University; First Affiliated Hospital Xi'an Jiaotong University; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; The First Affiliated Hospital of Zhengzhou University; Zhongnan Hospital; Third Affiliated Hospital, Sun Yat-Sen University; Jinhua Municipal Central Hospital; First Affiliated Hospital of Wenzhou Medical University; Wuhan TongJi Hospital; Third Affiliated Hospital of Xinjiang Medical University; First Affiliated Hospital of Harbin Medical University; Anhui Provincial Hospital; Beijing Tsinghua Changgeng Hospital
• Investigators: Principal Investigator: Weilin Wang, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China; Principal Investigator: Yuan Ding, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China; Principal Investigator: Zhongquan Sun, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 16, 2024
• First Submitted That Met QC Criteria: August 5, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 24, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Hepatocellular Carcinoma; Diagnosis
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Pathological Conditions, Signs and Symptoms; Carcinoma, Hepatocellular; Disease
• Other Study ID Numbers: 2024-0167

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No