Hepatocellular Carcinoma, Non-cirrhotic LiverNCT06364839
Liver Transplantation for Hepatocellular Carcinoma Arising in Non-cirrhotic Liver: a Propensity Score-matched Retrospective Cohort Study of Two National Databases
An observational study of Hepatocellular Carcinoma, Non-cirrhotic Liver, run by Xiao Xu at 1 site in China.
Trial summary
Background: Majority of liver transplantation (LT) recipients for hepatocellular carcinoma (HCC) were concomitant with liver cirrhosis, while few researches focusing on recipients without cirrhosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatocellular Carcinoma, Non-cirrhotic Liver
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2024to 25 Mar 2024
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Previously registered liver transplant recipients
Who may be able to join
- liver transplants, performed from January 2015 to December 2020
Who cannot join
- pediatric LT; LT for non-tumor lesions; LT for other malignant tumors (cholangiocarcinoma, carcinoma of gallbladder, mixed carcinoma, and secondary tumors); re-transplantation or combined liver-kidney transplantation; incomplete laboratory or clinical data; death within 1 week due to post-operative hemorrhage after LT.
Trial locations and contacts
1 site in 1 country.
About this study
Background: Majority of liver transplantation (LT) recipients for hepatocellular carcinoma (HCC) were concomitant with liver cirrhosis, while few researches focusing on recipients without cirrhosis. Here we aim to investigate the prognosis of non-cirrhosis HCC recipients, expecting to provide theoretical basis for further improvement of these patients.
Methods: This retrospective study analyze outcomes between adult HCC recipients arising in non-cirrhotic and cirrhotic liver from two national databases (CLTR and UNOS, January 2015 to December 2020). Based on important variables, 1:2 and 1:1 propensity score matching (PSM) were performed respectively.
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications were evaluated by postoperative imaging and serological examination
Including rejection after liver transplantation, vascular complications, new metabolic diseases and so on
Measured: 3 months
The overall survival rate was evaluated by follow-up investigation and outpatient review
Measured: 1-3 years
The tumor-free survival rate was evaluated by follow-up investigation and outpatient review
Measured: 1-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start20 Feb 2024
- Primary completion23 Mar 2024
- Study completion25 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma, Non-cirrhotic LiverStudies 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
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiao Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiao Xu, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364839
- Sponsor's protocol ID
- CT2024-ZJU-OBS7
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Transplantation for Hepatocellular Carcinoma Arising in Non-cirrhotic Liver: a Propensity Score-matched Retrospective Cohort Study of Two National Databases
- ClinicalTrials.gov ID
- NCT06364839
- Acronym / sponsor ID
- CT2024-ZJU-OBS7
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Xiao XuUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 23 Mar 2024 (actual)
- Study completion
- 25 Mar 2024 (actual)
- First posted
- 15 Apr 2024 (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.
Background: Majority of liver transplantation (LT) recipients for hepatocellular carcinoma (HCC) were concomitant with liver cirrhosis, while few researches focusing on recipients without cirrhosis. Here we aim to investigate the prognosis of non-cirrhosis HCC recipients, expecting to provide theoretical basis for further improvement of these patients.
Methods: This retrospective study analyze outcomes between adult HCC recipients arising in non-cirrhotic and cirrhotic liver from two national databases (CLTR and UNOS, January 2015 to December 2020). Based on important variables, 1:2 and 1:1 propensity score matching (PSM) were performed respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Previously registered liver transplant recipients
Key inclusion criteria (1 listed)
- liver transplants, performed from January 2015 to December 2020
Key exclusion criteria (1 listed)
- pediatric LT; LT for non-tumor lesions; LT for other malignant tumors (cholangiocarcinoma, carcinoma of gallbladder, mixed carcinoma, and secondary tumors); re-transplantation or combined liver-kidney transplantation; incomplete laboratory or clinical data; death within 1 week due to post-operative hemorrhage after LT.
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 |
|---|---|---|
| Other | – |
Primary outcome
Postoperative complications were evaluated by postoperative imaging and serological examination
Time frame: 3 months
Including rejection after liver transplantation, vascular complications, new metabolic diseases and so on
The overall survival rate was evaluated by follow-up investigation and outpatient review
Time frame: 1-3 years
The tumor-free survival rate was evaluated by follow-up investigation and outpatient review
Time frame: 1-3 years
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 15 Apr 2024.
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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.
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, Non-cirrhotic Liver, run by Xiao Xu at 1 site 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 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: finished, as of the sponsor's last update on 15 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 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?
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?
Postoperative complications were evaluated by postoperative imaging and serological examination (time frame: 3 months). The study lists 3 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 15 Apr 2024.