Hepatocellular CarcinomaNCT05823584
Cell-free DNA From Junction of Hepatitis B Virus Integration in HCC Patients for Monitoring Post-resection Recurrence
An observational study of Hepatocellular Carcinoma, run by TCM Biotech International Corp. at 1 site in Taiwan.
Trial summary
HBV DNA integration has been found in the chromosomes of about 90% of HBV-related HCC and the integration site is unique to individual HCC. The virus-host chimera DNA (vh-DNA) from HBV integration sites in HCC a reliable evidence even in the patient with a tiny tumor which is not large enough to be detected by the… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 207 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Dec 2019to 31 Dec 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients with HCC are scheduled to undergo hepatic resection or liver transplant.
Who may be able to join
- ≥20 years old.
- Subject who is diagnosed with HCC
- Subject who is scheduled to undergo hepatic resection or liver transplant.
Who cannot join
- Subject who should not treat with the contrast media (for imaging)
- Active malignancy (still under intensive cancer treatment or considered in progression) or disease free interval less than one year before entering the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cell-free DNA From the Junction of Hepatitis B Virus Integration in HCC Patients for Monitoring Post-resection Recurrence: A Comparison Study With Current Biomarkers
HBV DNA integration has been found in the chromosomes of about 90% of HBV-related HCC and the integration site is unique to individual HCC. The virus-host chimera DNA (vh-DNA) from HBV integration sites in HCC a reliable evidence even in the patient with a tiny tumor which is not large enough to be detected by the image scan.
The goal of this observational study is to compare the prediction ability of vh-DNA with the other biomarkers for monitoring the recurrent of HBV-related HCC. The main questions that aim to answer are the sensitivity and specificity of vh-DNA/AFP/ALP-L3/PIVKA-II/TERTC2280 when the gold standard is the guideline of HCC diagnosis.
Read more
The surgical tissues and plasma samples from the participants would be collected undergoing the HCC recession surgery when joining the study at the beginning, in order to identify the HBV integration in tumor by Capture NGS and quantify the specific vh-DNA in plasma by ddPCR as personalized biomarkers for minimal residual disease (MRD) monitoring. Moreover, the consistency of vh-DNA from tumor will be validated by pre-operative plasma.
Then the participants will be asked to performed the visit at 2, 5, 8, 11, 14 months after the HCC recession surgery. The plasma sample for vh-DNA/AFP/ AFP-L3/ PIVKA-II/ TERTp C228T testing and the image data from ultrasound, CT or MRI would also be collected at these visits. When the vh-DNA testing result is positive and there is no recurrence at 14 months after the HCC recession surgery, some participants will be asked to followed at 17, 20 months.
Researcher will compare the sensitivity, specificity and predict day of vh-DNA with AFP/ AFP-L3/ PIVKA-II/ TERTp C228T as a biomarker for HCC surveillance. The true value of this novel HBV chimera vh-DNA will be revealed. The results will also support to use for monitoring post-operative recurrence.
In addition, the investigators will explore the performance of TERTp C228T mutation from non-HBV HCC patients. As a different target of ctDNA for HCC, TERTp C228T will be identified using surgical tissues from HCC patients, and plasma samples from the same patient before/after operation will be tested by ddPCR . It will be evaluated that TERTp C228T is predictive or not for recurrence monitoring of HCC.
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Hepatitis b Virus, Biomarker, Cell-free DNA, cfDNA, Circulating tumor DNA, ctDNA, virus-host chimera DNA, Chimera DNA
- Medical subject headings
- Carcinoma, Hepatocellular, Hepatitis B
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity (vh-DNA vs AFP) (the vh-DNA which could be detected in the pre-operative plasma of participants.)
Compare the sensitivity of vh-DNA with AFP as a biomarker for HCC surveillance.
Measured: HCC recurrence within 14 months of post-operative.
Secondary outcomes (6)
Sensitivity (vh-DNA vs AFP) (the vh-DNA which could not be detected in the pre-operative plasma of participants.)
Compare the sensitivity of vh-DNA with AFP as a biomarker for HCC surveillance.
Measured: HCC recurrence within 14 months of post-operative.
Sensitivity (vh-DNA vs AFP-L3/PIVKA-II/TERTp C228T)
Compare the sensitivity of vh-DNA with AFP-L3/ PIVKA-II/ TERTp C228T as a biomarker for HCC surveillance.
Measured: HCC recurrence within 14 months of post-operative.
Specificity (vh-DNA vs AFP/AFP-L3/PIVKA-II/TERTp C228T)
Compare the specificity of vh-DNA with AFP/ AFP-L3/ PIVKA-II/ TERTp C228T as a biomarker for HCC surveillance.
Measured: The 14 months of post-operative.
Predicted days (vh-DNA vs AFP/AFP-L3/PIVKA-II/TERTp C228T)
Compare the predicted day of vh-DNA with AFP/AFP-L3/PIVKA-II/TERTp C228T as a biomarker before HCC recurrence.
Measured: HCC recurrence within 14 months of post-operative.
Clonality
To clarify the clonality of recurrent HCC is same as the original one or is a de novo one.
Measured: HCC recurrence within 14 months of post-operative.
Sensitivity (TERT C228T vs AFP/AFP-L3/PIVKA-II)
Compare the sensitivity of TERTp C228T with AFP/ AFP-L3/ PIVKA-II as a biomarker for HCC surveillance.
Measured: HCC recurrence within 14 months of post-operative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start22 Dec 2019
- Primary completion21 Jul 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- TCM Biotech International Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Taiwan University Hospital
- Responsible party
- Sponsor
- Investigators
- Pei-Jer Chen, Ph.D, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823584
- Sponsor's protocol ID
- ctDNA-HCC-01
- Status last verified
- Oct 2023
- First submitted
- 10 Apr 2023
- Last updated
- 10 Apr 2024
- 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 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cell-free DNA From the Junction of Hepatitis B Virus Integration in HCC Patients for Monitoring Post-resection Recurrence: A Comparison Study With Current Biomarkers
- ClinicalTrials.gov ID
- NCT05823584
- Acronym / sponsor ID
- ctDNA-HCC-01
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Hepatitis b Virus, Biomarker, Cell-free DNA, cfDNA, Circulating tumor DNA, ctDNA, virus-host chimera DNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- TCM Biotech International Corp.Industry (pharma, biotech, devices)
- Collaborators
- National Taiwan University Hospital
- Study start
- 22 Dec 2019 (actual)
- Primary completion
- 21 Jul 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 21 Apr 2023 (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.
HBV DNA integration has been found in the chromosomes of about 90% of HBV-related HCC and the integration site is unique to individual HCC. The virus-host chimera DNA (vh-DNA) from HBV integration sites in HCC a reliable evidence even in the patient with a tiny tumor which is not large enough to be detected by the image scan.
The goal of this observational study is to compare the prediction ability of vh-DNA with the other biomarkers for monitoring the recurrent of HBV-related HCC. The main questions that aim to answer are the sensitivity and specificity of vh-DNA/AFP/ALP-L3/PIVKA-II/TERTC2280 when the gold standard is the guideline of HCC diagnosis.
The surgical tissues and plasma samples from the participants would be collected undergoing the HCC recession surgery when joining the study at the beginning, in order to identify the HBV integration in tumor by Capture NGS and quantify the specific vh-DNA in plasma by ddPCR as personalized biomarkers for minimal residual disease (MRD) monitoring. Moreover, the consistency of vh-DNA from tumor will be validated by pre-operative plasma.
Then the participants will be asked to performed the visit at 2, 5, 8, 11, 14 months after the HCC recession surgery. The plasma sample for vh-DNA/AFP/ AFP-L3/ PIVKA-II/ TERTp C228T testing and the image data from ultrasound, CT or MRI would also be collected at these visits. When the vh-DNA testing result is positive and there is no recurrence at 14 months after the HCC recession surgery, some participants will be asked to followed at 17, 20 months.
Researcher will compare the sensitivity, specificity and predict day of vh-DNA with AFP/ AFP-L3/ PIVKA-II/ TERTp C228T as a biomarker for HCC surveillance. The true value of this novel HBV chimera vh-DNA will be revealed. The results will also support to use for monitoring post-operative recurrence.
In addition, the investigators will explore the performance of TERTp C228T mutation from non-HBV HCC patients. As a different target of ctDNA for HCC, TERTp C228T will be identified using surgical tissues from HCC patients, and plasma samples from the same patient before/after operation will be tested by ddPCR . It will be evaluated that TERTp C228T is predictive or not for recurrence monitoring of HCC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients with HCC are scheduled to undergo hepatic resection or liver transplant.
Key inclusion criteria (3 listed)
- ≥20 years old.
- Subject who is diagnosed with HCC
- Subject who is scheduled to undergo hepatic resection or liver transplant.
Key exclusion criteria (2 listed)
- Subject who should not treat with the contrast media (for imaging)
- Active malignancy (still under intensive cancer treatment or considered in progression) or disease free interval less than one year before entering the study.
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
Sensitivity (vh-DNA vs AFP) (the vh-DNA which could be detected in the pre-operative plasma of participants.)
Time frame: HCC recurrence within 14 months of post-operative.
Compare the sensitivity of vh-DNA with AFP as a biomarker for HCC surveillance.
6 secondary outcomes
Sensitivity (vh-DNA vs AFP) (the vh-DNA which could not be detected in the pre-operative plasma of participants.)
Time frame: HCC recurrence within 14 months of post-operative.
Sensitivity (vh-DNA vs AFP-L3/PIVKA-II/TERTp C228T)
Time frame: HCC recurrence within 14 months of post-operative.
Specificity (vh-DNA vs AFP/AFP-L3/PIVKA-II/TERTp C228T)
Time frame: The 14 months of post-operative.
Predicted days (vh-DNA vs AFP/AFP-L3/PIVKA-II/TERTp C228T)
Time frame: HCC recurrence within 14 months of post-operative.
Clonality
Time frame: HCC recurrence within 14 months of post-operative.
Sensitivity (TERT C228T vs AFP/AFP-L3/PIVKA-II)
Time frame: HCC recurrence within 14 months of post-operative.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- 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.
Pei-Jer Chen, Ph.D principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by TCM Biotech International Corp. at 1 site in Taiwan.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sensitivity (vh-DNA vs AFP) (the vh-DNA which could be detected in the pre-operative plasma of participants.) (time frame: HCC recurrence within 14 months of post-operative.). 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 10 Apr 2024.