Serum Biomarkers for Portal Hypertension in Cirrhosis (Pan-CHESS1802)

August 16, 2021 updated by: Xiaolong Qi, Nanfang Hospital of Southern Medical University

Serum Biomarkers Associated With Endothelial Dysfunction and Immune Inflammation for Portal Hypertension in Cirrhosis (Pan-CHESS1802)

This is a prospective, multi-center diagnostic trial conducted at 6 liver centers in China designed to study the correlation between serum biomarkers associated with endothelial dysfunction and immune inflammation and hepatic venous pressure gradient in cirrhosis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Hepatic venous pressure gradient (HVPG) is the gold standard for assessing portal pressure, of which the measurement is invasive and therefore not suitable for routine clinical practice. The detection of serum biomarkers is potential for noninvasive diagnosis of portal hypertension in cirrhosis. However, many are still in the exploratory phases of testing and are not yet ready to enter clinical practice. This study prospectively enrolled participants in 6 liver centers (Beijing YouAn Hospital, Shandong Provincial Hospital, Beijing Shijitan Hospital, Beijing Friendship Hospital, Xingtai People's Hospital, and 302 Hospital of PLA) in China designed to study the correlation between serum biomarkers associated with endothelial dysfunction and immune inflammation and HVPG in cirrhosis.

Study Type

Observational

Enrollment (Anticipated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing Friendship Hospital
        • Principal Investigator:
          • Yu Wang, MD
      • Beijing, China
        • Recruiting
        • 302 Hospital of PLA
        • Contact:
          • Ruizhao Qi, MD
        • Principal Investigator:
          • Ruizhao Qi, MD
      • Beijing, China
        • Recruiting
        • Beijing Shijitan Hospital
        • Contact:
          • Fuquan Liu, MD
        • Principal Investigator:
          • Fuquan Liu, MD
      • Beijing, China
        • Recruiting
        • Beijing YouAn Hospital
        • Contact:
          • Huiguo Ding, MD
        • Principal Investigator:
          • Huiguo Ding, MD
      • Jinan, China
        • Recruiting
        • Shandong Provincial Hospital
        • Contact:
          • Chunqing Zhang, MD
        • Principal Investigator:
          • Chunqing Zhang, MD
      • Xingtai, China
        • Recruiting
        • Xingtai People's Hospital
        • Principal Investigator:
          • Dengxiang Liu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cirrhotic portal hypertension

Description

Inclusion Criteria:

  • age 18-75 years;
  • confirmed cirrhosis based on histologic examination of liver or combined physical, laboratory, and radiologic findings, including a nodular surface, a coarse texture, and an enlarged caudate lobe of the liver.

Exclusion Criteria:

  • prior drug therapy (e.g. β-blocker, vasopressin) within two weeks
  • prior surgeries (e.g. TIPS, partial splenic embolization/ devascularization, splenectomy, liver transplantation)
  • non-sinusoidal portal hypertension & HCC inability to adhere to study procedures
  • pregnancy or unknown pregnancy status
  • no informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Overall eligible participants
Eligible participants will receive HVPG measurement by catheterization of a hepatic vein with a balloon catheter and run blood tests.
Procedure: HVPG measurement
HVPG obtained by means of catheterization of a hepatic vein with a balloon catheter.
Other Names:
  • Blood test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between serum biomarkers and HVPG
Time Frame: 1 day
Correlation between serum biomarkers and HVPG
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between serum biomarkers and HVPG in HBV subgroup
Time Frame: 1 day
Correlation between serum biomarkers and HVPG in a subgroup of patients with HBV-related cirrhosis
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Collaborators

Beijing Friendship Hospital
Beijing YouAn Hospital
Beijing 302 Hospital
Shandong Provincial Hospital
Beijing Shijitan Hospital, Capital Medical University
Xingtai People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2018

Primary Completion (Anticipated)

January 31, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

October 18, 2018

First Submitted That Met QC Criteria

October 18, 2018

First Posted (Actual)

October 22, 2018

Study Record Updates

Last Update Posted (Actual)

August 17, 2021

Last Update Submitted That Met QC Criteria

August 16, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pan-CHESS1802

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Undecided.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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