We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date August 8, 2022
First Posted Date August 10, 2022
Last Update Posted Date August 10, 2022
Estimated Study Start Date December 1, 2022
Estimated Primary Completion Date December 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 8, 2022)		 HCC screening positive [ Time Frame: 2 years ]
Data will suggest the probability of HCC
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Novel Biomarker Assay for Biomarker Assay for HCC Detection
Official Title Novel Biomarker Assay for HCC Detection and Monitoring Piedmont Transplant Institute and Genetron Health, Inc.
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Hepato-cellular Carcinoma
Intervention Not Provided
Study Groups/Cohorts
  • HCC
    HCC positive
  • Non HCC
    HCC negative
Publications * Qu C, Wang Y, Wang P, Chen K, Wang M, Zeng H, Lu J, Song Q, Diplas BH, Tan D, Fan C, Guo Q, Zhu Z, Yin H, Jiang L, Chen X, Zhao H, He H, Wang Y, Li G, Bi X, Zhao X, Chen T, Tang H, Lv C, Wang D, Chen W, Zhou J, Zhao H, Cai J, Wang X, Wang S, Yan H, Zeng YX, Cavenee WK, Jiao Y. Detection of early-stage hepatocellular carcinoma in asymptomatic HBsAg-seropositive individuals by liquid biopsy. Proc Natl Acad Sci U S A. 2019 Mar 26;116(13):6308-6312. doi: 10.1073/pnas.1819799116. Epub 2019 Mar 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: August 8, 2022)		 200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2025
Estimated Primary Completion Date December 1, 2024   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Moin Ahmad 12403506177 mahmad@genetronhealth.us
Contact: Hai Yan 3015080881 hyan@genetronhealth.us
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT05494853
Other Study ID Numbers GTH_HCC2022
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Genetron Health
Original Responsible Party Same as current
Current Study Sponsor Genetron Health
Original Study Sponsor Same as current
Collaborators Piedmont Transplant Institute. 1968 Peachtree Road, NW | 77 Building, 6th Floor | Atlanta, GA 30309
Investigators Not Provided
PRS Account Genetron Health
Verification Date August 2022