Clinical trial NCT05343832: Detection Evaluation of a Novel Blood-based DNA Methylation Assay in Early-stage Hepatocellular Carcinoma Patients
Official title: Detection Evaluation of a Novel Blood-based DNA Methylation Assay in Early-stage Hepatocellular Carcinoma Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Cancer
Lead sponsor: Genetron Health
Sponsor class: INDUSTRY
Collaborators: name: Third Affiliated Hospital, Sun Yat-Sen University
name: Guangzhou eighth People's Hospital ,Guangzhou Medilcal University
name: The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
name: West China Hospital
name: Beijing Youan Hospital,Capital Medical University Beijing Institute of Hepatology
name: Ruijin Hospital
name: Xiangya Hospital of Central South University
name: The First Affiliated Hospital of Zhengzhou University
name: Wuxi No.5 People's Hospital
name: Peking University First Hospital
First posted: 2022-04-25
Enrollment: 4816
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: All plasma samples and imaging results will be used to evaluate diagnostic(sensitivity and specificity) of the kit.
timeFrame: 2 months
measure: Plasma samples of patients with and without HCC to evaluate test performance(accuracy) of the kit. diagnostic(sensitivity and specificity) of the kit.
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Youan Hospital,Capital Medical University Beijing Institute of Hepatology
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
city: Chengdu
country: China
facility: West China School of Medicine/West China Hospital of Sichuan University
city: Guangzhou
country: China
facility: Guangzhou eighth People's Hospital ,Guangzhou Medilcal University
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
city: Nantong
country: China
facility: Nantong Tumor Hospital
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School
city: Wuxi
country: China
facility: Wuxi No.5 People's Hospital
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
Study officials:
References: