Cirrhosis； TumorNCT06060769
Study on the Quantitative Assessment of the Risk of Hepatocellular Carcinoma in Patients With Chronic Liver Disease Using Multi-parameter Magnetic Resonance Imaging
An observational study of Cirrhosis； Tumor, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
Quantitative MRI scanning parameters such as T1 mapping, T2 mapping, T1ρ, and elastography are used, combined with clinical and laboratory indicators, to predict the risk of liver cancer in patients with cirrhosis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cirrhosis； Tumor
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 31 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with chronic liver disease who may develop liver cancer.
Who may be able to join
- 1. Aged over 18 years old; 2. Liver function Child-Pugh classification A or B; 3. Patients with chronic liver disease who meet the diagnostic criteria for high-risk groups of liver cancer in the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 Edition)"; 4. Equipped with Gd-EOB-DTPA enhanced MRI scan images, including T1 mapping, T2 mapping, T2* mapping, T1ρ and other sequences; 5. With 5-year follow-up data.
Who cannot join
- 1. Patients who are unable to undergo MRI scanning due to claustrophobia, abnormal renal function, etc.; 2. Patients who have undergone liver surgery in the past; 3. Patients with major diseases such as heart failure and tumors.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Yaqin, Zhang
Zhuhai, Guangdong
Yaqin Zhang, 13719282895, zhyaqin@mail.sysu.edu.cn
About this study
Quantitative MRI scanning parameters such as T1 mapping, T2 mapping, T1ρ, and elastography are used, combined with clinical and laboratory indicators, to predict the risk of liver cancer in patients with cirrhosis.
Read the detailed description
Retrospectively and prospectively collect T1 mapping, T2 mapping, T2* mapping, T1ρ, elastography and other multi-parameter MRI sequence images and clinical and laboratory examination data from patients with liver cirrhosis, and conduct 5-year clinical follow-up and monitoring of all enrolled patients. Whether patients develop hepatocellular carcinoma, patients are divided into liver cancer occurrence group and non-hepatocellular carcinoma group according to clinical follow-up results. Cox proportional hazard analysis is used to compare the differences in clinical characteristics, laboratory tests, imaging characteristics, quantitative MRI parameters and other variables between the two groups of patients. , and calculate the hazard ratio for each variable; assign a score to each covariate based on the proportion of the hazard ratio in the multivariable model, and develop a nomogram to predict HCC risk by the total score.
- Conditions
- Cirrhosis； Tumor
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 |
|---|---|---|
| HCC group | Patients who develop HCC during follow-up | |
| non-HCC group | Patients who did not develop HCC during follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCC incidence rate
Rate of HCC among enrolled patients
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Sep 2023
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis； TumorStudies 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
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yaqin Zhang, MD, Ph.D, Study chair, Fifth Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060769
- Sponsor's protocol ID
- ZDWY.FSK.028
- Status last verified
- Sep 2023
- First submitted
- 25 Sep 2023
- Last updated
- 29 Sep 2023
- 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 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Quantitative Assessment of the Risk of Hepatocellular Carcinoma in Patients With Chronic Liver Disease Using Multi-parameter Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT06060769
- Acronym / sponsor ID
- ZDWY.FSK.028
- Conditions
- Cirrhosis； Tumor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 29 Sep 2023 (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.
Quantitative MRI scanning parameters such as T1 mapping, T2 mapping, T1ρ, and elastography are used, combined with clinical and laboratory indicators, to predict the risk of liver cancer in patients with cirrhosis.
Detailed description
Retrospectively and prospectively collect T1 mapping, T2 mapping, T2* mapping, T1ρ, elastography and other multi-parameter MRI sequence images and clinical and laboratory examination data from patients with liver cirrhosis, and conduct 5-year clinical follow-up and monitoring of all enrolled patients. Whether patients develop hepatocellular carcinoma, patients are divided into liver cancer occurrence group and non-hepatocellular carcinoma group according to clinical follow-up results. Cox proportional hazard analysis is used to compare the differences in clinical characteristics, laboratory tests, imaging characteristics, quantitative MRI parameters and other variables between the two groups of patients. , and calculate the hazard ratio for each variable; assign a score to each covariate based on the proportion of the hazard ratio in the multivariable model, and develop a nomogram to predict HCC risk by the total score.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCC group | – | –Patients who develop HCC during follow-up |
| non-HCC group | – | –Patients who did not develop HCC during follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic liver disease who may develop liver cancer.
Key inclusion criteria (1 listed)
- 1. Aged over 18 years old; 2. Liver function Child-Pugh classification A or B; 3. Patients with chronic liver disease who meet the diagnostic criteria for high-risk groups of liver cancer in the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 Edition)"; 4. Equipped with Gd-EOB-DTPA enhanced MRI scan images, including T1 mapping, T2 mapping, T2* mapping, T1ρ and other sequences; 5. With 5-year follow-up data.
Key exclusion criteria (1 listed)
- 1. Patients who are unable to undergo MRI scanning due to claustrophobia, abnormal renal function, etc.; 2. Patients who have undergone liver surgery in the past; 3. Patients with major diseases such as heart failure and tumors.
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
HCC incidence rate
Time frame: 5 years
Rate of HCC among enrolled patients
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Yaqin Zhang, MD, Ph.D study chair
Fifth Affiliated Hospital, Sun Yat-Sen University
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 Cirrhosis； Tumor, run by Fifth Affiliated Hospital, Sun Yat-Sen 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: looking for participants now, as of the sponsor's last update on 29 Sep 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yaqin Zhang, MD, Ph.D (13719282895, zhyaqin@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCC incidence rate (time frame: 5 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 29 Sep 2023.