Hepatocellular Carcinoma (HCC)NCT06626724
A Retrospective Cohort Study on Predicting Delayed Graft Function in Liver Transplant Patients with Hepatocellular Carcinoma: a Nomogram and Machine Learning Approaches.
An observational study of Hepatocellular Carcinoma (HCC) and DGF, run by Jian You at 1 site in China.
Trial summary
Background: This study aimed to develop a predictive model for delayed graft function (DGF) in liver transplant patients with hepatocellular carcinoma (HCC) based on preoperative biochemical indicators, using both logistic regression and XGBoost machine learning algorithms. Read more about this study
- Who is it for?
- Ages 18 to 75 days
- Conditions the study is for
- Hepatocellular Carcinoma (HCC), DGF
- What is being tested?
- Liver transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 131 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 30 Apr 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 18 to 75 days
- All sexes
- No healthy volunteers
- Child
Study population: Patients receiving a liver transplant between January 2020 and April 2024.
Who may be able to join
- Patients with liver cancer aged between 18 and 75 years.
- Patients who have received liver transplantation.
- Complete preoperative and postoperative medical imaging data, clinical records and pathological test reports are available.
Who cannot join
- Primary non-hepatocellular carcinoma
- Recipients were younger than 18 years and older than 75 years
- Due to incomplete or missing clinical data, this dataset did not meet the criteria for inclusion in the statistical analysis.
- Serious complications associated with liver transplantation, such as acute transplant rejection or transplant liver failure, occur within 7 days after surgery.
- Re-surgery within 7 days after surgery due to liver transplant-related complications or other surgical procedures, such as transplant site infection or other major surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Background: This study aimed to develop a predictive model for delayed graft function (DGF) in liver transplant patients with hepatocellular carcinoma (HCC) based on preoperative biochemical indicators, using both logistic regression and XGBoost machine learning algorithms.
Methods: A retrospective cohort study was conducted, including 131 liver transplant patients from January 2020 to April 2022. Preoperative biochemical markers and hematological parameters were analyzed. Logistic regression and XGBoost models were constructed to predict DGF, and their performance was evaluated using the area under the ROC curve (AUC). Shapley Additive Explanations (SHAP) analysis was employed to interpret the feature contributions.
- Conditions
- Hepatocellular Carcinoma (HCC), DGF
- Being tested
- Liver transplantation
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver transplantationProcedure or surgery
Liver transplantation for patients with hepatocellular carcinoma.
What is being measured
The primary outcome is the main question the study is designed to answer.
TBIL/AST/ALT/INR
Measured: Results of biochemical examination on the 7th day after liver transplantation in patients with hepatocellular carcinoma.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start1 Jan 2020
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies 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
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jian You
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jian You, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626724
- Sponsor's protocol ID
- Zhongnan Hospital
- Status last verified
- Oct 2024
- First submitted
- 1 Oct 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data are not publicly available, as participants in this study need their data for further analysis.
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Cohort Study on Predicting Delayed Graft Function in Liver Transplant Patients with Hepatocellular Carcinoma: a Nomogram and Machine Learning Approaches.
- ClinicalTrials.gov ID
- NCT06626724
- Acronym / sponsor ID
- Zhongnan Hospital
- Conditions
- Hepatocellular Carcinoma (HCC), DGF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Jian YouUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 4 Oct 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: This study aimed to develop a predictive model for delayed graft function (DGF) in liver transplant patients with hepatocellular carcinoma (HCC) based on preoperative biochemical indicators, using both logistic regression and XGBoost machine learning algorithms.
Methods: A retrospective cohort study was conducted, including 131 liver transplant patients from January 2020 to April 2022. Preoperative biochemical markers and hematological parameters were analyzed. Logistic regression and XGBoost models were constructed to predict DGF, and their performance was evaluated using the area under the ROC curve (AUC). Shapley Additive Explanations (SHAP) analysis was employed to interpret the feature contributions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients receiving a liver transplant between January 2020 and April 2024.
Key inclusion criteria (3 listed)
- Patients with liver cancer aged between 18 and 75 years.
- Patients who have received liver transplantation.
- Complete preoperative and postoperative medical imaging data, clinical records and pathological test reports are available.
Key exclusion criteria (5 listed)
- Primary non-hepatocellular carcinoma
- Recipients were younger than 18 years and older than 75 years
- Due to incomplete or missing clinical data, this dataset did not meet the criteria for inclusion in the statistical analysis.
- Serious complications associated with liver transplantation, such as acute transplant rejection or transplant liver failure, occur within 7 days after surgery.
- Re-surgery within 7 days after surgery due to liver transplant-related complications or other surgical procedures, such as transplant site infection or other major surgery.
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 |
|---|---|---|
| Liver transplantationLiver transplantation for patients with hepatocellular carcinoma. | Procedure or surgery | – |
Primary outcome
TBIL/AST/ALT/INR
Time frame: Results of biochemical examination on the 7th day after liver transplantation in patients with hepatocellular carcinoma.
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 4 Oct 2024.
- Individual participant dataSharing planned: No. The data are not publicly available, as participants in this study need their data for further analysis.
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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 (HCC) and DGF, run by Jian You 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 3 inclusion and 5 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 4 Oct 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?
TBIL/AST/ALT/INR (time frame: Results of biochemical examination on the 7th day after liver transplantation in patients with hepatocellular carcinoma.). 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 4 Oct 2024.