A Novel Imaging Based Quantitative Model-aided Detection of Portal Hypertension in Patients With Cirrhosis (CHESS2104)
NCT ID: NCT05068492
Last Updated: 2023-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
2000 participants
OBSERVATIONAL
2023-12-10
2025-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
An AI Model Based on Smartphone-derived Multimodality Images to Evaluate Portal Hypertension in Patients With Cirrhosis (CHESS2203)
NCT05402410
A Novel Spleen-dedicated Stiffness Measured by FibroScan to Evaluate Cirrhotic Portal Hypertension (CHESS2105)
NCT05052892
A Combined Model Based on Spleen Stiffness, Liver Stiffness and Platelets for Assessing Portal Hypertension in Compensated Cirrhosis (CHESS2202)
NCT05251272
Non-invasive Diagnosis of Portal Hypertension in Cirrhosis Based on Metabolomics Technology
NCT05551884
Radiomics Signature of Hepatic Venous Pressure Gradient (rHVPG) With CT Angiography (CHESS1701)
NCT03138915
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The development of radiomics technique provides an approach to solve abovementioned clinical issues. Based on artificial intelligence algorithms, radiomics harnesses mineable, high-resolution, and quantitative features from encrypted medical images, along with clinical or genetic data to produce evidence-based decision support system, to achieve the clinical targets including diagnosis, treatment effect evaluation, and prognosis prediction. In this project, aiming at development of a risk stratification system for hypertension management in cirrhosis, we will construct a standard-of-care database and utilize radiomics tool to construct the decision making system. We will take responsibility for achievement of organ and vessel segmentation, radiomic feature selection, and signature construction for prediction of hypertension classification, and accomplish the development of prototype system which would integrate four modules including database management, HVPG risk stratification application module, predicted outcome presentation module, and prognostic information curation module. This project will focus on two aspects which are correspondingly machine learning algorithms optimization and prototype system development, so as to promote the precision medicine in liver disease.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Training cohort
Training cohort was set to develop the novel non-invasive model for virtual HVPG
CT
enhanced CT with standard procedure
MRI
enhanced MRI with standard procedure
HVPG
HVPG measurements are performed by well-trained interventional radiologists in accordance with standard operating procedures
Ultrasound
Digestive ultrasound with standard procedure
Validation cohort
Validation cohort was set to validate the novel non-invasive model for virtual HVPG in different people in same environments
CT
enhanced CT with standard procedure
MRI
enhanced MRI with standard procedure
HVPG
HVPG measurements are performed by well-trained interventional radiologists in accordance with standard operating procedures
Ultrasound
Digestive ultrasound with standard procedure
Test cohort
Test cohort was set to test the novel non-invasive model for virtual HVPG in different environments
CT
enhanced CT with standard procedure
MRI
enhanced MRI with standard procedure
HVPG
HVPG measurements are performed by well-trained interventional radiologists in accordance with standard operating procedures
Ultrasound
Digestive ultrasound with standard procedure
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CT
enhanced CT with standard procedure
MRI
enhanced MRI with standard procedure
HVPG
HVPG measurements are performed by well-trained interventional radiologists in accordance with standard operating procedures
Ultrasound
Digestive ultrasound with standard procedure
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. confirmed cirrhosis (laboratory, imaging and clinical symptoms);
3. with ultrasound/CT/MRI within 1 month prior to HVPG measurement;
4. written informed consent.
Exclusion Criteria
2. liver cancer; chronic acute liver failure;
3. acute portal hypertension;
4. unreliable HVPG or ultrasound/CT/MRI results due to technical reasons.
5. with liver interventional therapy between HVPG and ultrasound/CT/MRI
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Portal Hypertension Alliance in China
UNKNOWN
Hepatopancreatobiliary Surgery Institute of Gansu Province
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Xiaolong Qi
Chief, Institute of Portal Hypertension, The First Hospital of Lanzhou University
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Xiaolong Qi, Prof.
Role: PRINCIPAL_INVESTIGATOR
CHESS Center, Institute of Portal Hypertension, The First Hospital of Lanzhou University, Lanzhou, China
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Liu Y, Ning Z, Ormeci N, An W, Yu Q, Han K, Huang Y, Liu D, Liu F, Li Z, Ding H, Luo H, Zuo C, Liu C, Wang J, Zhang C, Ji J, Wang W, Wang Z, Wang W, Yuan M, Li L, Zhao Z, Wang G, Li M, Liu Q, Lei J, Liu C, Tang T, Akcalar S, Celebioglu E, Ustuner E, Bilgic S, Ellik Z, Asiller OO, Liu Z, Teng G, Chen Y, Hou J, Li X, He X, Dong J, Tian J, Liang P, Ju S, Zhang Y, Qi X. Deep Convolutional Neural Network-Aided Detection of Portal Hypertension in Patients With Cirrhosis. Clin Gastroenterol Hepatol. 2020 Dec;18(13):2998-3007.e5. doi: 10.1016/j.cgh.2020.03.034. Epub 2020 Mar 21.
Liu F, Ning Z, Liu Y, Liu D, Tian J, Luo H, An W, Huang Y, Zou J, Liu C, Liu C, Wang L, Liu Z, Qi R, Zuo C, Zhang Q, Wang J, Zhao D, Duan Y, Peng B, Qi X, Zhang Y, Yang Y, Hou J, Dong J, Li Z, Ding H, Zhang Y, Qi X. Development and validation of a radiomics signature for clinically significant portal hypertension in cirrhosis (CHESS1701): a prospective multicenter study. EBioMedicine. 2018 Oct;36:151-158. doi: 10.1016/j.ebiom.2018.09.023. Epub 2018 Sep 27.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CHESS2104
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.