Chronic Liver Disease and CirrhosisNCT06741904
Non-invasive Methods for Predicting Decompensation of Chronic Liver Disease
An observational study of Chronic Liver Disease and Cirrhosis, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Preliminary studies have suggested that non-invasive methods can not only be applied to CSPH but also to predict the risk of decompensation in cirrhosis. However, there is a lack of clinical evidence, and more research is needed to provide such evidence. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Liver Disease and Cirrhosis
- How many people
- 2,334 participants
- Where
- 1 siteChina
- Study dates
- 16 Dec 2024to 31 Dec 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Chronic Liver Disease
Who may be able to join
- Aged over 18 years and under 80 years; ② Underlying chronic liver disease (etiology not specified);
- Liver stiffness measurement (LSM) greater than 10 kPa or cirrhosis (diagnosed by imaging or histology);
- Voluntarily signing an informed consent form.
Who cannot join
- Have undergone orthotopic liver transplantation or Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure;
- History of liver cancer or other types of cancer diagnosed in the past or currently;
- Acute or chronic portal vein thrombosis; ④ History of splenectomy or splenic embolization; ⑤ Currently in a decompensated stage (with complications such as variceal bleeding, moderate to severe ascites, hepatic encephalopathy, etc.).
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
Nanfang Hospital of Southern Medical University
Guangzhou, Guangzhou
About this study
Official title: Noninvasive Methods for Predicting the Occurrence of Decompensation in Chronic Liver Disease: a Prospective, Observational, Multicenter Study
Preliminary studies have suggested that non-invasive methods can not only be applied to CSPH but also to predict the risk of decompensation in cirrhosis. However, there is a lack of clinical evidence, and more research is needed to provide such evidence. Especially in China, where the etiology of cirrhosis is prevalent, there is a large population of patients with hepatitis B cirrhosis undergoing antiviral treatment. Exploring the value of non-invasive methods in predicting decompensation events in these patients can not only expand the clinical application of non-invasive methods but also provide effective non-invasive screening and management strategies for patients with cirrhosis at different risk levels.
Primary Objective: The main purpose of this study is to evaluate the predictive effectiveness of non-invasive methods (based on liver and spleen stiffness) for the occurrence of decompensation in chronic liver disease (CLD).
Read more
Secondary Objectives: To establish different predictive models for the occurrence of decompensation in CLD and to assess their predictive effectiveness as non-invasive methods for decompensation in CLD.
Approximately 2334 individuals will participate in this study at 17 different health care Setting.The study will last for 4 years, including 1 year of enrollment and 3 years of follow-up. Patients will be seen at 6-month intervals, and all examination results of patients as well as decompensation events, liver cancer, and death will be recorded.
- Conditions
- Chronic Liver Disease and Cirrhosis
- Medical subject headings
- Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Decompensation events
Decompensated events included ascites, variceal bleeding, and hepatic encephalopathy
Measured: Patients were followed from the time of enrollment for a maximum of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start16 Dec 2024 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Liver Disease and CirrhosisStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical 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
- Prospective
- Enrolment
- 2,334 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741904
- Sponsor's protocol ID
- NFEC-2024-427
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dajti E, Ravaioli F, Zykus R, Rautou PE, Elkrief L, Grgurevic I, Stefanescu H, Hirooka M, Fraquelli M, Rosselli M, Chang PEJ, Piscaglia F, Reiberger T, Llop E, Mueller S, Marasco G, Berzigotti A, Colli A, Festi D, Colecchia A; Spleen Stiffness-IPD-MA Study Group. Accuracy of spleen stiffness measurement for the diagnosis of clinically significant portal hypertension in patients with compensated advanced chronic liver disease: a systematic review and individual patient data meta-analysis. Lancet Gastroenterol Hepatol. 2023 Sep;8(9):816-828. doi: 10.1016/S2468-1253(23)00150-4. Epub 2023 Jul 18.
PubMed 37478880
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Methods for Predicting the Occurrence of Decompensation in Chronic Liver Disease: a Prospective, Observational, Multicenter Study
- ClinicalTrials.gov ID
- NCT06741904
- Acronym / sponsor ID
- NFEC-2024-427
- Conditions
- Chronic Liver Disease and Cirrhosis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,334 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 16 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 19 Dec 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.
Preliminary studies have suggested that non-invasive methods can not only be applied to CSPH but also to predict the risk of decompensation in cirrhosis. However, there is a lack of clinical evidence, and more research is needed to provide such evidence. Especially in China, where the etiology of cirrhosis is prevalent, there is a large population of patients with hepatitis B cirrhosis undergoing antiviral treatment. Exploring the value of non-invasive methods in predicting decompensation events in these patients can not only expand the clinical application of non-invasive methods but also provide effective non-invasive screening and management strategies for patients with cirrhosis at different risk levels.
Primary Objective: The main purpose of this study is to evaluate the predictive effectiveness of non-invasive methods (based on liver and spleen stiffness) for the occurrence of decompensation in chronic liver disease (CLD).
Secondary Objectives: To establish different predictive models for the occurrence of decompensation in CLD and to assess their predictive effectiveness as non-invasive methods for decompensation in CLD.
Approximately 2334 individuals will participate in this study at 17 different health care Setting.The study will last for 4 years, including 1 year of enrollment and 3 years of follow-up. Patients will be seen at 6-month intervals, and all examination results of patients as well as decompensation events, liver cancer, and death will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Chronic Liver Disease
Key inclusion criteria (3 listed)
- Aged over 18 years and under 80 years; ② Underlying chronic liver disease (etiology not specified);
Key exclusion criteria (3 listed)
- Have undergone orthotopic liver transplantation or Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure;
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
Decompensation events
Time frame: Patients were followed from the time of enrollment for a maximum of 3 years
Decompensated events included ascites, variceal bleeding, and hepatic encephalopathy
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 19 Dec 2024.
- Background: PubMed 37478880Dajti E, Ravaioli F, Zykus R, Rautou PE, Elkrief L, Grgurevic I, Stefanescu H, Hirooka M, Fraquelli M, Rosselli M, Chang PEJ, Piscaglia F, Reiberger T, Llop E, Mueller S, Marasco G, Berzigotti A, Colli A, Festi D, Colecchia A; Spleen Stiffness-IPD-MA Study Group. Accuracy of spleen stiffness measurement for the diagnosis of clinically significant portal hypertension in patients with compensated advanced chronic liver disease: a systematic review and individual patient data meta-analysis. Lancet Gastroenterol Hepatol. 2023 Sep;8(9):816-828. doi: 10.1016/S2468-1253(23)00150-4. Epub 2023 Jul 18.
- Individual participant dataSharing planned: Undecided
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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.
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 Chronic Liver Disease and Cirrhosis, run by Nanfang Hospital, Southern Medical 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 3 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: enrolling by invitation, as of the sponsor's last update on 19 Dec 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?
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?
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?
Decompensation events (time frame: Patients were followed from the time of enrollment for a maximum of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06741904, which also lists 1 linked publication.
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 19 Dec 2024.