Novel Biomarker Assay for Biomarker Assay for HCC Detection

Not yet recruiting

• Conditions: Hepato-cellular Carcinoma

• Registration Number: NCT05494853
• Lead Sponsor: Genetron Health

Brief Summary

The primary purpose of this study is to assess the performance feasibility of Genetron's novel HCC liquid biopsy biomarkers assay for early detection. Piedmont Transplant Institute will provide a longitudinally collected blood sample from all HCC cases (mixture of early and advanced stage HCC) and cirrhosis control to Genetron Health after obtaining informed consent.

Detailed Description

HCC is a leading cause of cancer-related deaths in the US. Early detection is crucial to improve the outcome of HCC. HCC surveillance is recommended for early detection of HCC in patients with cirrhosis. However, current HCC surveillance tests, such as liver ultrasound and AFP have relatively low accuracy for the detection of early-stage HCC. Genetron Health recently published on novel liquid biopsy biomarker for detection of HCC in China. The biomarker showed excellent performance for the detection of HCC among the at-risk population, most of whom had HBV infection. It is crucial to validate the performance of this novel biomarker in an independent population of patients with different etiology of liver disease outside of China. As this novel biomarker is useful in the detection of small HCC, it may also serve as an excellent biomarker for assessment of treatment response and monitoring of recurrence.

The primary purpose of this study is to assess the performance feasibility of Genetron's novel HCC liquid biopsy biomarkers assay for early detection. Piedmont Transplant Institute will provide a longitudinally collected blood sample from all HCC cases (mixture of early and advanced stage HCC) and cirrhosis control to Genetron Health after obtaining informed consent. Genetron Health will analyze the blood sample and provide data to the PI, for internal review purposes. Should the initial pilot study be successful, the parties will have a discussion to expand the number of cases and control samples and consider conducting a multicenter prospective study.

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-08
• Study First Submitted QC: 2022-08-08
• Last Update Submitted: 2022-08-08
• Study First Posted: 2022-08-10
• Last Update Posted: 2022-08-10
• Study Start: 2022-12-01
• Primary Completion: 2024-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients diagnosed with HCC (based on histology or radiology according to AASLD guideline) or liver cirrhosis (based on the clinical history of hepatic encephalopathy, thrombocytopenia, radiologic features of the nodular liver, features of portal hypertension such as ascites, splenomegaly, or MR elastogram or fibroscan showing result consistent with cirrhosis)
• Willing and able to provide informed consent to participate in this study

Exclusion Criteria

• Unable to provide blood samples
• Age less than 18 years of age
• Patient who have active cancers (excluding HCC) in the past five years, except for nonmelanoma skin cancer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HCC screening positive	2 years	Data will suggest the probability of HCC