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

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ClinicalTrials.gov Identifier: NCT03713606
Recruitment Status : Recruiting
First Posted : October 22, 2018
Last Update Posted : December 5, 2018
Sponsor:
Collaborators:
Beijing YouAn Hospital
Shandong Provincial Hospital
Beijing Shijitan Hospital
Beijing Friendship Hospital
Xingtai People's Hospital
Beijing 302 Hospital
Information provided by (Responsible Party):
Xiaolong Qi, Nanfang Hospital of Southern Medical University

Tracking Information
First Submitted Date October 18, 2018
First Posted Date October 22, 2018
Last Update Posted Date December 5, 2018
Actual Study Start Date September 30, 2018
Estimated Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 18, 2018)
Correlation between serum biomarkers and HVPG [ Time Frame: 1 day ]
Correlation between serum biomarkers and HVPG
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03713606 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 18, 2018)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Serum Biomarkers for Portal Hypertension in Cirrhosis (Pan-CHESS1802)
Official Title Serum Biomarkers Associated With Endothelial Dysfunction and Immune Inflammation for Portal Hypertension in Cirrhosis (Pan-CHESS1802)
Brief Summary 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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood serum
Sampling Method Non-Probability Sample
Study Population Cirrhotic portal hypertension
Condition Hypertension, Portal
Intervention Procedure: HVPG measurement
HVPG obtained by means of catheterization of a hepatic vein with a balloon catheter.
Other Name: Blood test
Study Groups/Cohorts Overall eligible participants
Eligible participants will receive HVPG measurement by catheterization of a hepatic vein with a balloon catheter and run blood tests.
Intervention: Procedure: HVPG measurement
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 18, 2018)
75
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 1, 2019
Estimated Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Xiaolong Qi, M.D. +86 18588602600 qixiaolong@vip.163.com
Contact: Yanna Liu +86 15625076784 lauyenna@126.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03713606
Other Study ID Numbers Pan-CHESS1802
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: Undecided.
Responsible Party Xiaolong Qi, Nanfang Hospital of Southern Medical University
Study Sponsor Nanfang Hospital of Southern Medical University
Collaborators
  • Beijing YouAn Hospital
  • Shandong Provincial Hospital
  • Beijing Shijitan Hospital
  • Beijing Friendship Hospital
  • Xingtai People's Hospital
  • Beijing 302 Hospital
Investigators
Principal Investigator: Xiaolong Qi, M.D. Nanfang Hospital of Southern Medical University
PRS Account Nanfang Hospital of Southern Medical University
Verification Date December 2018