Hepatocellular CarcinomaNCT03668158
Multi-center Study on Therapy-oriented Molecular Subtyping of Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma, run by Zhejiang University.
Trial summary
The purpose of this study is to establish molecular subtyping of HCC. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- 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 patient
Who may be able to join
- Liver transplantation due to HCC within Hangzhou criteria
Who cannot join
- Liver transplantation due to HCC beyond Hangzhou criteria Liver transplantation due to other disease except HCC Multiple organ transplantation
About this study
The purpose of this study is to establish molecular subtyping of HCC.
Read the detailed description
Hepatocellular carcinoma is one of the most common malignant tumors in the world with high incidence and mortality. Liver transplantation is the most effective treatment for HCC and is in high demand in China. However, recurrence of HCC among liver transplantation recipients is still a great challenge and threat to the survival of recipients. So it is of great significance to establish molecular subtyping of HCC and achieve precise selection of recipients. Based on large scales of samples, the investigator's study aims to establish multi-omics characteristic profiles of liver transplantation for HCC in integration of apparent biological characteristics, clinical management and prognostic information by utilizing genomics, transcriptomics and proteomics, etc. This study will contribute to the therapy-oriented molecular subtyping of HCC.
- Conditions
- Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
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 |
|---|---|---|
| recurrent HCC | recurrent HCC after LT | |
| non-recurrent HCC | non- recurrent HCC after LT |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence rate
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 posted12 Sep 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
- Retrospective
- 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
- NCT03668158
- Sponsor's protocol ID
- ZJHZXU2017
- Status last verified
- Oct 2018
- First submitted
- 10 Sep 2018
- Last updated
- 24 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Study on Therapy-oriented Molecular Subtyping of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03668158
- Acronym / sponsor ID
- ZJHZXU2017
- 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
- 12 Sep 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.
The purpose of this study is to establish molecular subtyping of HCC.
Detailed description
Hepatocellular carcinoma is one of the most common malignant tumors in the world with high incidence and mortality. Liver transplantation is the most effective treatment for HCC and is in high demand in China. However, recurrence of HCC among liver transplantation recipients is still a great challenge and threat to the survival of recipients. So it is of great significance to establish molecular subtyping of HCC and achieve precise selection of recipients. Based on large scales of samples, the investigator's study aims to establish multi-omics characteristic profiles of liver transplantation for HCC in integration of apparent biological characteristics, clinical management and prognostic information by utilizing genomics, transcriptomics and proteomics, etc. This study will contribute to the therapy-oriented molecular subtyping of HCC.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| recurrent HCC | – | –recurrent HCC after LT |
| non-recurrent HCC | – | –non- recurrent HCC after LT |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalization patient
Key inclusion criteria (1 listed)
- Liver transplantation due to HCC within Hangzhou criteria
Key exclusion criteria (1 listed)
- Liver transplantation due to HCC beyond Hangzhou criteria Liver transplantation due to other disease except HCC Multiple organ transplantation
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
recurrence rate
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
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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 24 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?
recurrence rate (time frame: 2 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 24 Oct 2018.