Novel Biomarker Assay for Biomarker Assay for HCC Detection (GTH_HCC)
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|ClinicalTrials.gov Identifier: NCT05494853|
Recruitment Status : Not yet recruiting
First Posted : August 10, 2022
Last Update Posted : August 10, 2022
|Condition or disease|
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 Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Novel Biomarker Assay for HCC Detection and Monitoring Piedmont Transplant Institute and Genetron Health, Inc.|
|Estimated Study Start Date :||December 1, 2022|
|Estimated Primary Completion Date :||December 1, 2024|
|Estimated Study Completion Date :||December 1, 2025|
- HCC screening positive [ Time Frame: 2 years ]Data will suggest the probability of HCC
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05494853
|Contact: Moin Ahmademail@example.com|
|Contact: Hai Yanfirstname.lastname@example.org|