Hepato-cellular CarcinomaGTH_HCCNCT05494853
Novel Biomarker Assay for Biomarker Assay for HCC Detection
An observational study of Hepato-cellular Carcinoma, run by Genetron Health.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepato-cellular Carcinoma
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Novel Biomarker Assay for HCC Detection and Monitoring Piedmont Transplant Institute and Genetron Health, Inc.
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.
Read the 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.
- Conditions
- Hepato-cellular Carcinoma
- Keywords
- HCC Screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HCC | HCC positive | |
| Non HCC | HCC negative |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCC screening positive
Data will suggest the probability of HCC
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepato-cellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genetron Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Piedmont Transplant Institute. 1968 Peachtree Road, NW | 77 Building, 6th Floor | Atlanta, GA 30309
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494853
- Sponsor's protocol ID
- GTH_HCC2022
- Acronym
- GTH_HCC
- Status last verified
- Aug 2022
- First submitted
- 8 Aug 2022
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30858324
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Biomarker Assay for HCC Detection and Monitoring Piedmont Transplant Institute and Genetron Health, Inc.
- ClinicalTrials.gov ID
- NCT05494853
- Acronym / sponsor ID
- GTH_HCC / GTH_HCC2022
- Conditions
- Hepato-cellular Carcinoma
- Keywords
- HCC Screening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Genetron HealthIndustry (pharma, biotech, devices)
- Collaborators
- Piedmont Transplant Institute. 1968 Peachtree Road, NW | 77 Building, 6th Floor | Atlanta, GA 30309
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 10 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCC | – | –HCC positive |
| Non HCC | – | –HCC negative |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HCC screening positive
Time frame: 2 years
Data will suggest the probability of HCC
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Background: PubMed 30858324Qu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepato-cellular Carcinoma, run by Genetron Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Moin Ahmad (12403506177, mahmad@genetronhealth.us), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCC screening positive (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05494853, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.