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Novel Biomarker Assay for Biomarker Assay for HCC Detection (GTH_HCC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05494853
Recruitment Status : Not yet recruiting
First Posted : August 10, 2022
Last Update Posted : August 10, 2022
Sponsor:
Collaborator:
Piedmont Transplant Institute. 1968 Peachtree Road, NW | 77 Building, 6th Floor | Atlanta, GA 30309
Information provided by (Responsible Party):
Genetron Health

Study Description
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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.

Condition or disease
Hepato-cellular Carcinoma

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 Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Groups and Cohorts
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Group/Cohort
HCC
HCC positive
Non HCC
HCC negative


Outcome Measures
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Primary Outcome Measures :
  1. HCC screening positive [ Time Frame: 2 years ]
    Data will suggest the probability of HCC


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05494853


Contacts
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Contact: Moin Ahmad 12403506177 mahmad@genetronhealth.us
Contact: Hai Yan 3015080881 hyan@genetronhealth.us

Sponsors and Collaborators
Genetron Health
Piedmont Transplant Institute. 1968 Peachtree Road, NW | 77 Building, 6th Floor | Atlanta, GA 30309
More Information
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Publications:

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Responsible Party: Genetron Health
ClinicalTrials.gov Identifier: NCT05494853    
Other Study ID Numbers: GTH_HCC2022
First Posted: August 10, 2022    Key Record Dates
Last Update Posted: August 10, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Genetron Health:
HCC Screening
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases