Liver CancerNCT05343832
Detection Evaluation of a Novel Blood-based DNA Methylation Assay in Early-stage Hepatocellular Carcinoma Patients
An observational study of Liver Cancer, run by Genetron Health at 9 sites in China.
Trial summary
This trail is a multi-center,prospective observational study aimed to detect early-stage Hepatocellular Carcinoma by a Novel Blood-based DNA Methylation Assay(named Genetron HCC Methylation PCR Kit ). The accuracy of the kit will also be evaluated . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Cancer
- How many people
- 4,816 participants
- Where
- 9 sitesChina
- Study dates
- 29 Nov 2021to 25 Apr 2023
- 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 Any age
- Child, Adult, Older adult
Study population: Patients diagnosed with primary hepatocellular carcinoma, or with high risk factors for liver cancer such as HBV and/or HCV infection, alcoholic liver disease, non-alcoholic steatohepatitis, long-term consumption of food contaminated with aflatoxin, various other causes of liver cirrhosis, and patients with a family history of liver cancer, etc.
Who may be able to join
- Have high risk factors for liver cancer such as HBV and/or HCV infection, alcoholic liver disease, non-alcoholic steatohepatitis, long-term consumption of food contaminated with aflatoxin, liver cirrhosis caused by various other reasons, and family history of liver cancer Wait;
- I or my legal representative can read, understand and sign the informed consent;
- Agree to provide blood samples, be able to receive imaging examinations and have good clinical compliance;
- The complete clinical basic information includes: the patient's unique traceability number (ID number/outpatient clinic number/medical insurance card number), age, gender, etc.
- Confirmed primary hepatocellular carcinoma or confirmed non-HCC;
- I or my legal representative can read, understand and sign the informed consent;
- Agree to provide blood samples and have good clinical compliance;
- The basic clinical information is complete, including: the patient's unique traceability number (ID number/outpatient clinic number/medical insurance card number), age, gender, imaging and/or pathological diagnosis results (for patients with primary liver cancer), imaging examination confirmed non-identical Liver cancer (non-HCC patients).
Who cannot join
- pregnant women;
- Have received an organ transplant;
- Diagnosed with other tumors;
- The investigators judged that they were not eligible for inclusion.
- Test performance evaluation:
- pregnant women;
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- Have received an organ transplant;
- Non-HCC patients diagnosed with other tumors;
- Patients with primary hepatocellular carcinoma combined with other tumors;
- The investigator judges that they are not eligible for inclusion.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Beijing Youan Hospital,Capital Medical University Beijing Institute of Hepatology
Beijing
Xiangya Hospital of Central South University
Changsha
West China School of Medicine/West China Hospital of Sichuan University
Chengdu
Guangzhou eighth People's Hospital ,Guangzhou Medilcal University
Guangzhou
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou
Nantong Tumor Hospital
Nantong
Ruijin Hospital, Shanghai Jiaotong University School
Shanghai
Wuxi No.5 People's Hospital
Wuxi
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
About this study
This trail is a multi-center,prospective observational study aimed to detect early-stage Hepatocellular Carcinoma by a Novel Blood-based DNA Methylation Assay(named Genetron HCC Methylation PCR Kit ). The accuracy of the kit will also be evaluated . The trail will be enroll approximately 4816 participants, including participants with HCC or benign diseases, and high risk factors for liver cancer.
Read the detailed description
Diagnostic performance evaluation:
Alpha-fetoprotein (AFP), liver ultrasound (US), dynamic contrast enhanced MRI and the kit examination will be performed on high-risk participants of primary liver cancer.
For subjects with typical imaging findings of hepatocellular carcinoma but an intrahepatic nodule diameter of ≤2 cm, an imaging study will be added to the above.
According to the clinical diagnostic criteria of primary liver cancer, the diagnostic performance of the kit, liver ultrasound examination (US) combined with alpha fetoprotein (AFP) detection will be evaluated, and the sensitivity of the kit, the kit combined with AFP, the kit combined with AFP and US, AFP combined with US screening for primary liver cancer will be compared.
Test performance evaluation:
Plasma samples of patients with and without HCC diagnosed according to the clinical diagnostic criteria of primary HCC will be collected and examined simultaneously by the kit and high-throughput human methylation sequencing (NGS sequencing).
- Conditions
- Liver Cancer
- Medical subject headings
- Liver Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
All plasma samples and imaging results will be used to evaluate diagnostic(sensitivity and specificity) of the kit.
Alpha-fetoprotein (AFP), liver ultrasound (US), dynamic contrast enhanced MRI and the kit examination will be performed on high-risk participants of primary liver cancer.
For subjects with typical imaging findings of hepatocellular carcinoma but an intrahepatic nodule diameter of ≤2 cm, an imaging study will be added to the above.
According to the clinical diagnostic criteria of primary liver cancer, the diagnostic performance of the kit, liver ultrasound examination (US) combined with alpha fetoprotein (AFP) detection will be evaluated, and the sensitivity of the kit, the kit combined with AFP, the kit combined with AFP and US, AFP combined with US screening for primary liver cancer will be compared.
Measured: 2 months
Plasma samples of patients with and without HCC to evaluate test performance(accuracy) of the kit. diagnostic(sensitivity and specificity) of the kit.
Following the principle of simultaneous blinding, blood samples were collected from liver cancer patients and non-HCC patients who had been diagnosed according to the clinical diagnostic criteria for primary liver cancer. The subjects were coded, and the selected samples were tested by the kit and the comparison method high-throughput human methylation sequencing (NGS sequencing method), and the test results were compared.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start29 Nov 2021
- Primary completion5 Mar 2023 (estimated)
- Study completion25 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 4,816 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genetron Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou eighth People's Hospital ,Guangzhou Medilcal University, The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China, West China Hospital, Beijing Youan Hospital,Capital Medical University Beijing Institute of Hepatology, Ruijin Hospital, Xiangya Hospital of Central South University, The First Affiliated Hospital of Zhengzhou University, Wuxi No.5 People's Hospital, Peking University First Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05343832
- Sponsor's protocol ID
- 20210280
- Status last verified
- Apr 2022
- First submitted
- 19 Apr 2022
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection Evaluation of a Novel Blood-based DNA Methylation Assay in Early-stage Hepatocellular Carcinoma Patients
- ClinicalTrials.gov ID
- NCT05343832
- Acronym / sponsor ID
- 20210280
- Conditions
- Liver Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,816 participants (estimated)
- Lead sponsor
- Genetron HealthIndustry (pharma, biotech, devices)
- Collaborators
- Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou eighth People's Hospital ,Guangzhou Medilcal University, The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China, West China Hospital, Beijing Youan Hospital,Capital Medical University Beijing Institute of Hepatology, Ruijin Hospital, Xiangya Hospital of Central South University, The First Affiliated Hospital of Zhengzhou University, Wuxi No.5 People's Hospital, Peking University First Hospital
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 5 Mar 2023 (estimated)
- Study completion
- 25 Apr 2023 (estimated)
- First posted
- 25 Apr 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.
This trail is a multi-center,prospective observational study aimed to detect early-stage Hepatocellular Carcinoma by a Novel Blood-based DNA Methylation Assay(named Genetron HCC Methylation PCR Kit ). The accuracy of the kit will also be evaluated . The trail will be enroll approximately 4816 participants, including participants with HCC or benign diseases, and high risk factors for liver cancer.
Detailed description
Diagnostic performance evaluation:
Alpha-fetoprotein (AFP), liver ultrasound (US), dynamic contrast enhanced MRI and the kit examination will be performed on high-risk participants of primary liver cancer.
For subjects with typical imaging findings of hepatocellular carcinoma but an intrahepatic nodule diameter of ≤2 cm, an imaging study will be added to the above.
According to the clinical diagnostic criteria of primary liver cancer, the diagnostic performance of the kit, liver ultrasound examination (US) combined with alpha fetoprotein (AFP) detection will be evaluated, and the sensitivity of the kit, the kit combined with AFP, the kit combined with AFP and US, AFP combined with US screening for primary liver cancer will be compared.
Test performance evaluation:
Plasma samples of patients with and without HCC diagnosed according to the clinical diagnostic criteria of primary HCC will be collected and examined simultaneously by the kit and high-throughput human methylation sequencing (NGS sequencing).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with primary hepatocellular carcinoma, or with high risk factors for liver cancer such as HBV and/or HCV infection, alcoholic liver disease, non-alcoholic steatohepatitis, long-term consumption of food contaminated with aflatoxin, various other causes of liver cirrhosis, and patients with a family history of liver cancer, etc.
Key inclusion criteria (8 listed)
- Have high risk factors for liver cancer such as HBV and/or HCV infection, alcoholic liver disease, non-alcoholic steatohepatitis, long-term consumption of food contaminated with aflatoxin, liver cirrhosis caused by various other reasons, and family history of liver cancer Wait;
- I or my legal representative can read, understand and sign the informed consent;
- Agree to provide blood samples, be able to receive imaging examinations and have good clinical compliance;
- The complete clinical basic information includes: the patient's unique traceability number (ID number/outpatient clinic number/medical insurance card number), age, gender, etc.
- Confirmed primary hepatocellular carcinoma or confirmed non-HCC;
Key exclusion criteria (10 listed)
- pregnant women;
- Have received an organ transplant;
- Diagnosed with other tumors;
- The investigators judged that they were not eligible for inclusion.
- pregnant women;
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
All plasma samples and imaging results will be used to evaluate diagnostic(sensitivity and specificity) of the kit.
Time frame: 2 months
Alpha-fetoprotein (AFP), liver ultrasound (US), dynamic contrast enhanced MRI and the kit examination will be performed on high-risk participants of primary liver cancer. For subjects with typical imaging findings of hepatocellular carcinoma but an intrahepatic nodule diameter of ≤2 cm, an imaging study will be added to the above. According to the clinical diagnostic criteria of primary liver cancer, the diagnostic performance of the kit, liver ultrasound examination (US) combined with alpha fetoprotein (AFP) detection will be evaluated, and the sensitivity of the kit, the kit combined with AFP, the kit combined with AFP and US, AFP combined with US screening for primary liver cancer will be compared.
Plasma samples of patients with and without HCC to evaluate test performance(accuracy) of the kit. diagnostic(sensitivity and specificity) of the kit.
Time frame: 2 months
Following the principle of simultaneous blinding, blood samples were collected from liver cancer patients and non-HCC patients who had been diagnosed according to the clinical diagnostic criteria for primary liver cancer. The subjects were coded, and the selected samples were tested by the kit and the comparison method high-throughput human methylation sequencing (NGS sequencing method), and the test results were compared.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cancer, run by Genetron Health at 9 sites in China.
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 8 inclusion and 10 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 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All plasma samples and imaging results will be used to evaluate diagnostic(sensitivity and specificity) of the kit. (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2022.