Novel Biomarker Assay for Biomarker Assay for HCC Detection
GTH_HCC
Novel Biomarker Assay for HCC Detection and Monitoring Piedmont Transplant Institute and Genetron Health, Inc.
1 other identifier
observational
200
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2022
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2022
CompletedFirst Posted
Study publicly available on registry
August 10, 2022
CompletedStudy Start
First participant enrolled
December 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedAugust 10, 2022
August 1, 2022
2 years
August 8, 2022
August 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HCC screening positive
Data will suggest the probability of HCC
2 years
Study Arms (2)
HCC
HCC positive
Non HCC
HCC negative
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 30858324BACKGROUND
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2022
First Posted
August 10, 2022
Study Start
December 1, 2022
Primary Completion
December 1, 2024
Study Completion
December 1, 2025
Last Updated
August 10, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share