Novel Biomarker Assay for Biomarker Assay for HCC Detection

Trial Title: Novel Biomarker Assay for Biomarker Assay for HCC Detection

NCT ID: NCT05494853

Condition: Hepato-cellular Carcinoma

Conditions: Official terms:
Carcinoma, Hepatocellular

Conditions: Keywords:
HCC Screening

Study type: Observational

Overall status: Not yet recruiting

Study design:

Time perspective: Prospective

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.

Criteria for eligibility:

Study pop:
cirrhotic patients without HCC, early intermediate stage HCC, advanced-stage HCC, and patients who remained in remission after curative treatment. ASH, fatty liver, NASH, HCV are the most common etiology of HCC and cirrhosis in our cohort.

Sampling method: Probability Sample
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Start date: December 1, 2022

Completion date: December 1, 2025

Lead sponsor:
Agency: Genetron Health
Agency class: Industry

Collaborator:
Agency: Piedmont Transplant Institute. 1968 Peachtree Road, NW | 77 Building, 6th Floor | Atlanta, GA 30309
Agency class: Other

Source: Genetron Health

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05494853