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

Recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Diagnostic Test: Proteomics

• Registration Number: NCT06544083
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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 300 subjects, including 100 subjects with liver cancer, 100 subjects with benign diseases, and 100 healthy subjects. The study is divided into two phases, and the first phase of the study will enroll 150 subjects, including 50 subjects with liver cancer, 50 subjects with benign disease, and 50 healthy subjects. The second phase of the study will enroll 150 subjects, including 50 cancer subjects, 50 benign disease subjects, and 50 healthy subjects.

Study Timeline

• Status Verified: 2024-02
• Study Start: 2024-02-05
• Study First Submitted: 2024-04-16
• Study First Submitted QC: 2024-08-05
• Last Update Submitted: 2024-08-05
• Study First Posted: 2024-08-09
• Last Update Posted: 2024-08-09
• Primary Completion: 2026-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Benign liver lesions group	Proteomics	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
Hepatocellular carcinoma group	Proteomics	Patients with histologically or cytological, imaging confirmed untreated hepatocellular carcinoma.
Healthy people group	Proteomics	People without any liver disease

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China