Hepatocellular CarcinomaNCT03708705
Liquid Biopsy-based Monitoring System for Relapse of HCC After Liver Transplantation: A Multi-center and Prospective Study
An observational study of Hepatocellular Carcinoma, run by Zhejiang University.
Trial summary
This study aims to develop a novel, reliable, liquid biopsy-based biomarker system for relapse of HCC associated with hepatitis B after liver transplantation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Risk model of tumor relapse
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2018to 1 Jul 2020
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: hospitalization patients
Who may be able to join
- transplants for HCC
Who cannot join
- Liver transplantation due to other disease
About this study
Official title: Liquid Biopsy-based Monitoring System for Relapse of Hepatocellular Carcinoma Associated With Hepatitis B After Liver Transplantation: A Multi-center and Prospective Study
This study aims to develop a novel, reliable, liquid biopsy-based biomarker system for relapse of HCC associated with hepatitis B after liver transplantation.
Read the detailed description
Relapse of hepatocellular carcinoma (HCC) is one of the leading causes of death after liver transplantation (LT). Detection of cancer at an earlier stage of the disease can be critical to improve patient survival. Liquid biopsy is a revolutionary technique that is opening previously unexpected perspectives. It consists of circulating extracellular vesicles, nucleic acids (DNA and RNA) and circulating tumor cells. The detection and isolation of circulating tumor cells, circulating tumor DNA and exosomes, as a source of genomic and proteomic information in patients with cancer. Regarding these promising and potential transformative tools, as well as the issues still needed to be addressed for adopting various liquid biopsy approaches into clinical practice. This study aims to develop a novel, reliable, liquid biopsy-based biomarker system for relapse of HCC associated with hepatitis B after liver transplantation.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Risk model of tumor relapse
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk model of tumor relapseOther
Also called Risk model
High risk factor model of tumor relapse after liver transplantation
| Study group | Role | What they receive |
|---|---|---|
| Relapse | Relapse of tumor within two years after liver transplantation Receives: Other: Risk model of tumor relapse | |
| Non-relapse | Non-relapse of tumor within two years after liver transplantation Receives: Other: Risk model of tumor relapse |
What is being measured
The primary outcome is the main question the study is designed to answer.
relapse rate of tumor
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start20 Nov 2018 (estimated)
- Primary completion1 May 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
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.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao Xu, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708705
- Sponsor's protocol ID
- ZJUXU1177
- Status last verified
- Oct 2018
- First submitted
- 13 Oct 2018
- Last updated
- 19 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liquid Biopsy-based Monitoring System for Relapse of Hepatocellular Carcinoma Associated With Hepatitis B After Liver Transplantation: A Multi-center and Prospective Study
- ClinicalTrials.gov ID
- NCT03708705
- Acronym / sponsor ID
- ZJUXU1177
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 20 Nov 2018 (estimated)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 17 Oct 2018 (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 study aims to develop a novel, reliable, liquid biopsy-based biomarker system for relapse of HCC associated with hepatitis B after liver transplantation.
Detailed description
Relapse of hepatocellular carcinoma (HCC) is one of the leading causes of death after liver transplantation (LT). Detection of cancer at an earlier stage of the disease can be critical to improve patient survival. Liquid biopsy is a revolutionary technique that is opening previously unexpected perspectives. It consists of circulating extracellular vesicles, nucleic acids (DNA and RNA) and circulating tumor cells. The detection and isolation of circulating tumor cells, circulating tumor DNA and exosomes, as a source of genomic and proteomic information in patients with cancer. Regarding these promising and potential transformative tools, as well as the issues still needed to be addressed for adopting various liquid biopsy approaches into clinical practice. This study aims to develop a novel, reliable, liquid biopsy-based biomarker system for relapse of HCC associated with hepatitis B after liver transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Relapse | – | Other: Risk model of tumor relapseRelapse of tumor within two years after liver transplantation |
| Non-relapse | – | Other: Risk model of tumor relapseNon-relapse of tumor within two years after liver transplantation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hospitalization patients
Key inclusion criteria (1 listed)
- transplants for HCC
Key exclusion criteria (1 listed)
- Liver transplantation due to other disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk model of tumor relapseAlso: Risk modelHigh risk factor model of tumor relapse after liver transplantation | Other | Non-relapse, Relapse |
Primary outcome
relapse rate of tumor
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2018.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Zhejiang University.
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 1 inclusion and 1 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 19 Oct 2018. 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?
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?
relapse rate of tumor (time frame: two years). 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 19 Oct 2018.