Detection Evaluation of a Novel Blood-based DNA Methylation Assay in Early-stage Hepatocellular Carcinoma Patients

NCT05343832 | Unknown

• 1 other identifier: 20210280
• Study Type: observational
• Target: 4,816
• Locations: 1 country
• Sites: 9

Brief Summary

This trail is a multi-center,prospective observational study aimed to detect early-stage Hepatocellular Carcinoma by a Novel Blood-based DNA Methylation Assay(named Genetron HCC Methylation PCR Kit ). The accuracy of the kit will also be evaluated . The trail will be enroll approximately 4816 participants, including participants with HCC or benign diseases, and high risk factors for liver cancer.

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (2)

• All plasma samples and imaging results will be used to evaluate diagnostic(sensitivity and specificity) of the kit.

  Alpha-fetoprotein (AFP), liver ultrasound (US), dynamic contrast enhanced MRI and the kit examination will be performed on high-risk participants of primary liver cancer. For subjects with typical imaging findings of hepatocellular carcinoma but an intrahepatic nodule diameter of ≤2 cm, an imaging study will be added to the above. According to the clinical diagnostic criteria of primary liver cancer, the diagnostic performance of the kit, liver ultrasound examination (US) combined with alpha fetoprotein (AFP) detection will be evaluated, and the sensitivity of the kit, the kit combined with AFP, the kit combined with AFP and US, AFP combined with US screening for primary liver cancer will be compared.

  2 months

• Plasma samples of patients with and without HCC to evaluate test performance(accuracy) of the kit. diagnostic(sensitivity and specificity) of the kit.

  Following the principle of simultaneous blinding, blood samples were collected from liver cancer patients and non-HCC patients who had been diagnosed according to the clinical diagnostic criteria for primary liver cancer. The subjects were coded, and the selected samples were tested by the kit and the comparison method high-throughput human methylation sequencing (NGS sequencing method), and the test results were compared.

  2 months

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with primary hepatocellular carcinoma, or with high risk factors for liver cancer such as HBV and/or HCV infection, alcoholic liver disease, non-alcoholic steatohepatitis, long-term consumption of food contaminated with aflatoxin, various other causes of liver cirrhosis, and patients with a family history of liver cancer, etc.

You may qualify if:

• Have high risk factors for liver cancer such as HBV and/or HCV infection, alcoholic liver disease, non-alcoholic steatohepatitis, long-term consumption of food contaminated with aflatoxin, liver cirrhosis caused by various other reasons, and family history of liver cancer Wait;
• I or my legal representative can read, understand and sign the informed consent;
• Agree to provide blood samples, be able to receive imaging examinations and have good clinical compliance;
• The complete clinical basic information includes: the patient's unique traceability number (ID number/outpatient clinic number/medical insurance card number), age, gender, etc.

You may not qualify if:

• pregnant women;
• Have received an organ transplant;
• Diagnosed with other tumors;
• Test performance evaluation:
• Confirmed primary hepatocellular carcinoma or confirmed non-HCC;
• I or my legal representative can read, understand and sign the informed consent;
• Agree to provide blood samples and have good clinical compliance;
• The basic clinical information is complete, including: the patient's unique traceability number (ID number/outpatient clinic number/medical insurance card number), age, gender, imaging and/or pathological diagnosis results (for patients with primary liver cancer), imaging examination confirmed non-identical Liver cancer (non-HCC patients).
• pregnant women;
• Have received an organ transplant;
• Non-HCC patients diagnosed with other tumors;
• Patients with primary hepatocellular carcinoma combined with other tumors;

Sponsors & Collaborators

• Genetron Health: lead
• Third Affiliated Hospital, Sun Yat-Sen University: collaborator
• Guangzhou eighth People's Hospital ,Guangzhou Medilcal University: collaborator
• The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China: collaborator
• West China Hospital: collaborator
• Beijing Youan Hospital,Capital Medical University Beijing Institute of Hepatology: collaborator
• Ruijin Hospital: collaborator
• Xiangya Hospital of Central South University: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Wuxi No.5 People's Hospital: collaborator
• Peking University First Hospital: collaborator

Study Sites (9)

Beijing Youan Hospital,Capital Medical University Beijing Institute of Hepatology

Beijing, China

Location

Xiangya Hospital of Central South University

Changsha, China

Location

West China School of Medicine/West China Hospital of Sichuan University

Chengdu, China

Location

Guangzhou eighth People's Hospital ,Guangzhou Medilcal University

Guangzhou, China

Location

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, China

Location

Nantong Tumor Hospital

Nantong, China

Location

Ruijin Hospital, Shanghai Jiaotong University School

Shanghai, China

Location

Wuxi No.5 People's Hospital

Wuxi, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Location

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: April 25, 2022
• Study Start: November 29, 2021
• Primary Completion: March 5, 2023
• Study Completion: April 25, 2023
• Last Updated: May 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)