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

NCT06544083 | Recruiting

• 1 other identifier: 2024-0167
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Diagnosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Presence or absence of intrahepatic and extrahepatic metastases of liver cancer

  up to 2 years

Study Arms (3)

Hepatocellular carcinoma group

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

Diagnostic Test: Proteomics

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

Healthy people group

People without any liver disease

Diagnostic Test: Proteomics

Interventions

Proteomics DIAGNOSTIC_TEST

Proteomic is performed on all blood samples.

Benign liver lesions group; Healthy people group; Hepatocellular carcinoma group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.
• Patients with histologically or cytological, radiographically confirmed hepatocellular carcinoma.

You may not qualify if:

• 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.
• Having other malignant tumors or multiple primary tumors at the same time.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• 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
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• Wuhan TongJi Hospital: collaborator
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Disease

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weilin Wang

CONTACT

13606642087; wam@zju.edu.cn

Yuan Ding

CONTACT

18858101960; dingyuan@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: August 9, 2024
• Study Start: February 5, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 27, 2026

Record last verified: 2026-05

Locations

CN (1)