Hepatocellular CarcinomaNCT03981848
Radiomics-based Non-invasive Classifier Research for HCC-related Liver Transplantation
An observational study of Hepatocellular Carcinoma and Liver Transplantation, run by Zhejiang University.
Trial summary
The purpose of this study is to establish a non-invasive radiomics method to filter high recurrent-risk liver transplantation recipient population Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Transplantation, Magnetic Resonance Imaging
- What is being tested?
- Risk model of tumor relapse
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jul 2019to Dec 2021
- 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
- All patients had postoperative pathological diagnosis of HCC
- All patients had underwent contrast-enhanced MRI scan within 2 weeks before liver transplantation
Who cannot join
- patients whose pathological diagnosis is not HCC
- patients whose CT images were affected by strong imaging artifacts, i.e. artifacts obscuring more than 10% of whole volume of interest
- patients whose clinical data or CT images were missing
About this study
The purpose of this study is to establish a non-invasive radiomics method to filter high recurrent-risk liver transplantation recipient population
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 a non-invasive way to filter high liver transplantation recipient population before transplantation. Based on large scales of pre-treatment MR images, the investigator's study aims to establish a non-invasive radiomics method to filter high recurrent-risk liver transplantation recipient population. This study will contribute to the precise selection of HCC-related liver transplantation recipients.
- 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.
tumor recurrent status
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 posted11 Jun 2019
- Study startJul 2019 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionDec 2021 (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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University
- Responsible party
- Principal investigator, Xiao Xu, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981848
- Sponsor's protocol ID
- 2019ZJUXX-001
- Status last verified
- Jun 2019
- First submitted
- 10 Jun 2019
- Last updated
- 11 Jun 2019
- 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 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiomics-based Non-invasive Classifier Research for HCC-related Liver Transplantation
- ClinicalTrials.gov ID
- NCT03981848
- Acronym / sponsor ID
- 2019ZJUXX-001
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Fudan University
- Study start
- Jul 2019 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 11 Jun 2019 (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 a non-invasive radiomics method to filter high recurrent-risk liver transplantation recipient population
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 a non-invasive way to filter high liver transplantation recipient population before transplantation. Based on large scales of pre-treatment MR images, the investigator's study aims to establish a non-invasive radiomics method to filter high recurrent-risk liver transplantation recipient population. This study will contribute to the precise selection of HCC-related liver transplantation recipients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- 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 (2 listed)
- All patients had postoperative pathological diagnosis of HCC
- All patients had underwent contrast-enhanced MRI scan within 2 weeks before liver transplantation
Key exclusion criteria (3 listed)
- patients whose pathological diagnosis is not HCC
- patients whose CT images were affected by strong imaging artifacts, i.e. artifacts obscuring more than 10% of whole volume of interest
- patients whose clinical data or CT images were missing
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
tumor recurrent status
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 11 Jun 2019.
Related trials for Hepatocellular Carcinoma
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
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and Liver Transplantation, 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 2 inclusion and 3 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 11 Jun 2019. 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?
tumor recurrent status (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 11 Jun 2019.