Cancer of LiverNCT05643833
Impact of Gender on the Outcome of Liver Transplantation for Hepatocellular Carcinoma
An observational study of Cancer of Liver, run by Zhejiang University at 1 site in China.
Trial summary
This is a large-scale study in China to provide evidence and insights in the role of gender in LT for HCC by analyzing the data of 3769 recipients with HCC registered in the China Liver Transplant Registry. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cancer of Liver
- How many people
- 3,769 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 15 Oct 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 3769 HCC patients underwent liver transplant with the age between 18-65 years old were studied.
Who may be able to join
- The patients with liver transplants performed from January 2015 to December 2020, whose clinicopathological data were registered in the CLTR.
Who cannot join
- Patients with following features were excluded: with concurrent other malignancies, pathologically-confirmed tumor types other than HCC, such as intrahepatic cholangiocarcinoma (ICC), combined hepatocellular cholangiocarcinoma (cHCC-CC), fibrolamellar hepatocellular carcinoma (FLC) or secondary metastatic tumor; without histological confirmation of HCC for transplantation. The patients who received living donor liver transplantation, split liver transplantation, reduced-size liver transplantation or simultaneous transplantation were also excluded. Next, pediatric patients (<18 years) or senile patients (>65 years) and those patients who died within six months after transplantation were also excluded. Finally, the patients with type-1 and type-2 portal vein tumor thrombus (PVTT), tumor metastasis, having doubtful or contradictory data or missing essential data for analysis, re-transplantation during follow-up time were excluded as well.
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
About this study
Official title: Impact of Gender on the Outcome of Liver Transplantation for Hepatocellular Carcinoma: A Multicenter Retrospective Study in China
This is a large-scale study in China to provide evidence and insights in the role of gender in LT for HCC by analyzing the data of 3769 recipients with HCC registered in the China Liver Transplant Registry.
- Conditions
- Cancer of Liver
- Being tested
- no intervention
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Male recipient | Not described Receives: Other: no intervention | |
| Female recipient | Not described Receives: Other: no intervention | |
| Male donor | Not described Receives: Other: no intervention | |
| Female donor | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
the overall survival of liver transplant recipient with HCC
Measured: January 2015 to December 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start1 Jan 2021
- Primary completion30 May 2022
- Study completion15 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of LiverStudies 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
- 3,769 participants (actual)
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
- NCT05643833
- Sponsor's protocol ID
- CT2022-ZJU-OBS1
- Status last verified
- Nov 2022
- First submitted
- 29 Nov 2022
- Last updated
- 9 Dec 2022
- Results posted
- 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 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Gender on the Outcome of Liver Transplantation for Hepatocellular Carcinoma: A Multicenter Retrospective Study in China
- ClinicalTrials.gov ID
- NCT05643833
- Acronym / sponsor ID
- CT2022-ZJU-OBS1
- Conditions
- Cancer of Liver
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,769 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 9 Dec 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 is a large-scale study in China to provide evidence and insights in the role of gender in LT for HCC by analyzing the data of 3769 recipients with HCC registered in the China Liver Transplant Registry.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Male recipient | – | Other: no intervention |
| Female recipient | – | Other: no intervention |
| Male donor | – | Other: no intervention |
| Female donor | – | Other: no intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 3769 HCC patients underwent liver transplant with the age between 18-65 years old were studied.
Key inclusion criteria (1 listed)
- The patients with liver transplants performed from January 2015 to December 2020, whose clinicopathological data were registered in the CLTR.
Key exclusion criteria (1 listed)
- Patients with following features were excluded: with concurrent other malignancies, pathologically-confirmed tumor types other than HCC, such as intrahepatic cholangiocarcinoma (ICC), combined hepatocellular cholangiocarcinoma (cHCC-CC), fibrolamellar hepatocellular carcinoma (FLC) or secondary metastatic tumor; without histological confirmation of HCC for transplantation. The patients who received living donor liver transplantation, split liver transplantation, reduced-size liver transplantation or simultaneous transplantation were also excluded. Next, pediatric patients (<18 years) or senile patients (>65 years) and those patients who died within six months after transplantation were also excluded. Finally, the patients with type-1 and type-2 portal vein tumor thrombus (PVTT), tumor metastasis, having doubtful or contradictory data or missing essential data for analysis, re-transplantation during follow-up time were excluded as well.
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 |
|---|---|---|
| no interventionno intervention | Other | Female donor, Female recipient, Male donor, Male recipient |
Primary outcome
Overall survival
Time frame: January 2015 to December 2020
the overall survival of liver transplant recipient with HCC
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 9 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Cancer of Liver
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
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 Cancer of Liver, run by Zhejiang University 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 9 Dec 2022. 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?
Overall survival (time frame: January 2015 to December 2020). 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 9 Dec 2022.