Status:
UNKNOWN
Detection Evaluation of a Novel Blood-based DNA Methylation Assay in Early-stage Hepatocellular Carcinoma Patients
Lead Sponsor:
Genetron Health
Collaborating Sponsors:
Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou eighth People's Hospital ,Guangzhou Medilcal University
Conditions:
Liver Cancer
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 )....
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 c...
Eligibility Criteria
Inclusion
- Diagnostic performance evaluation:
- 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.
Exclusion
- pregnant women;
- Have received an organ transplant;
- Diagnosed with other tumors;
- The investigators judged that they were not eligible for inclusion.
- Test performance evaluation:
- Inclusion Criteria:
- 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).
Key Trial Info
Start Date :
November 29 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 25 2023
Estimated Enrollment :
4816 Patients enrolled
Trial Details
Trial ID
NCT05343832
Start Date
November 29 2021
End Date
April 25 2023
Last Update
May 11 2022
Active Locations (9)
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1
Beijing Youan Hospital,Capital Medical University Beijing Institute of Hepatology
Beijing, China
2
Xiangya Hospital of Central South University
Changsha, China
3
West China School of Medicine/West China Hospital of Sichuan University
Chengdu, China
4
Guangzhou eighth People's Hospital ,Guangzhou Medilcal University
Guangzhou, China