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

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

NCT ID: NCT06544083

Condition: Hepatocellular Carcinoma

Conditions: Official terms:
Carcinoma, Hepatocellular
Liver Neoplasms

Conditions: Keywords:
Hepatocellular Carcinoma
Diagnosis

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: Proteomics
Description: Proteomic is performed on all blood samples.
Arm group label: Benign liver lesions group
Arm group label: Healthy people group
Arm group label: Hepatocellular carcinoma group

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.

Criteria for eligibility:

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

Sampling method: Probability Sample
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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: 2nd Affiliated Hospital, School of Medicine, Zhejiang University

Address:
City: Hangzhou
Zip: 310009
Country: China

Status: Recruiting

Contact:
Last name: Weilin Wang

Phone: +86 13606642087
Email: wam@zju.edu.cn

Start date: February 5, 2024

Completion date: February 28, 2026

Lead sponsor:
Agency: Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency class: Other

Source: Second Affiliated Hospital, School of Medicine, Zhejiang University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06544083