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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Liver Cancer

Detailed Description

Diagnostic performance evaluation:

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.

Test performance evaluation:

Plasma samples of patients with and without HCC diagnosed according to the clinical diagnostic criteria of primary HCC will be collected and examined simultaneously by the kit and high-throughput human methylation sequencing (NGS sequencing).

• Study Type: Observational
• Enrollment (Anticipated): 4816

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Youan Hospital,Capital Medical University Beijing Institute of Hepatology
  • Changsha, China
    • Xiangya Hospital of Central South University
  • Chengdu, China
    • West China School of Medicine/West China Hospital of Sichuan University
  • Guangzhou, China
    • Guangzhou eighth People's Hospital ,Guangzhou Medilcal University
  • Guangzhou, China
    • The Third Affiliated Hospital of Sun Yat-sen University
  • Nantong, China
    • Nantong Tumor Hospital
  • Shanghai, China
    • Ruijin Hospital, Shanghai Jiaotong University School
  • Wuxi, China
    • Wuxi No.5 People's Hospital
  • Zhengzhou, China
    • The First Affiliated Hospital of Zhengzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: N/A

• 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.

Description

Diagnostic performance evaluation:

Inclusion Criteria:

1. 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;
2. I or my legal representative can read, understand and sign the informed consent;
3. Agree to provide blood samples, be able to receive imaging examinations and have good clinical compliance;
4. The complete clinical basic information includes: the patient's unique traceability number (ID number/outpatient clinic number/medical insurance card number), age, gender, etc.

Exclusion Criteria:

1. pregnant women;
2. Have received an organ transplant;
3. Diagnosed with other tumors;
4. The investigators judged that they were not eligible for inclusion.

Test performance evaluation:

Inclusion Criteria:

1. Confirmed primary hepatocellular carcinoma or confirmed non-HCC;
2. I or my legal representative can read, understand and sign the informed consent;
3. Agree to provide blood samples and have good clinical compliance;
4. 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).

Exclusion Criteria:

1. pregnant women;
2. Have received an organ transplant;
3. Non-HCC patients diagnosed with other tumors;
4. Patients with primary hepatocellular carcinoma combined with other tumors;
5. The investigator judges that they are not eligible for inclusion.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 29, 2021
• Primary Completion (ANTICIPATED): March 5, 2023
• Study Completion (ANTICIPATED): April 25, 2023

Study Registration Dates

• First Submitted: April 19, 2022
• First Submitted That Met QC Criteria: April 19, 2022
• First Posted (ACTUAL): April 25, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 6, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma, Hepatocellular
• Other Study ID Numbers: 20210280

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No