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

NCT ID: NCT06544083

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-05
• Study Completion Date: 2026-02-28

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Hepatocellular carcinoma group

Patients with histologically or cytological, imaging confirmed untreated hepatocellular carcinoma.

Proteomics

Intervention Type: DIAGNOSTIC_TEST

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

Proteomics

Intervention Type: DIAGNOSTIC_TEST

Proteomic is performed on all blood samples.

Healthy people group

People without any liver disease

Proteomics

Intervention Type: DIAGNOSTIC_TEST

Proteomic is performed on all blood samples.

Interventions

Proteomics

Proteomic is performed on all blood samples.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Weilin Wang

Role: PRINCIPAL_INVESTIGATOR

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Yuan Ding

Role: PRINCIPAL_INVESTIGATOR

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Zhongquan Sun

Role: PRINCIPAL_INVESTIGATOR

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Locations

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Weilin Wang

Role: CONTACT

wam@zju.edu.cn

13606642087

Yuan Ding

Role: CONTACT

dingyuan@zju.edu.cn

18858101960

Facility Contacts

Weilin Wang

Role: primary

wam@zju.edu.cn

+86 13606642087

Other Identifiers

2024-0167

Identifier Type: -

Identifier Source: org_study_id