AzTrials
AzTrials

Compensated CirrhosisNCT03990753

Microbiome/Peptidome-based Model for Non-invasive Detection of High-risk Gastroesophageal Varices in Compensated Cirrhosis (CHESS1901/APPHA1901)

An observational study of Compensated Cirrhosis, run by Nanfang Hospital, Southern Medical University at 14 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Variceal hemorrhage is a lethal complication in patients with cirrhosis and portal hypertension. Identification of varices needing treatment in compensated cirrhosis is, therefore, of great therapeutic and prognostic importance. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Compensated Cirrhosis
What is being tested?
esophagogastroduodenoscopy
How many people
1,000 participants
Where
14 sitesin 3 countries
Study dates
13 Jun 2019to 12 Jun 2022
Phase
Observational
Are there results?
None posted in the registry

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants with compensated cirrhosis

Who may be able to join

  • age 18-75 years;
  • confirmed compensated cirrhosis based on liver biopsy or clinical findings;
  • without decompensated events (e.g. ascites, bleeding, or overt encephalopathy);
  • scheduled to undergo esophagogastroduodenoscopy;
  • estimated survival time> 24 months, and model for end-stage liver disease (MELD) score< 19, and without liver transplant;
  • with written informed consent.

Who cannot join

  • contradictions for esophagogastroduodenoscopy;
  • use of antibiotics, prebiotics, probiotics and proton pump inhibitors within 3 months upon recruitment.
  • pregnancy or unknown pregnancy status.

Trial locations and contacts

14 sites in 3 countries.

Xiaolong Qi, MD contact

+8618588602600

qixiaolong@vip.163.com

14 sites in 3 countries

China12 sites, 12 recruiting

  • Guangdong Second Provincial General Hospital

    Guangzhou, Guangdong

    Ming Xu, MD

    Ming Xu, MD

    Not yet recruiting

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong

    Jinlin Hou, MD

    Jinlin Hou, MD

    Not yet recruiting

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong

    Hua Mao, MD

    Hua Mao, MD

    Not yet recruiting

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

    Xiangpeng Hu, MD

    Jun Ye, MD

    Not yet recruiting

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu

    Xiaorong Mao, MD

    Xiaorong Mao, MD

    Recruiting

  • Zhejiang University Lishui Hospital

    Lishui, Zhejiang

    Jiansong Ji, MD

    Jiansong Ji, MD

    Not yet recruiting

  • Zhongda Hospital, Medical School, Southeast University

    Nanjing, Jiangsu

    Ruihua Shi, MD

    Ruihua Shi, MD

    Not yet recruiting

  • The Sixth People's Hospital of Shenyang

    Shenyang, Liaoning

    Yiying Song, MD

    Yiying Song, MD

    Not yet recruiting

  • Tianjin Second People's Hospital

    Tianjin, Tianjin Municipality

    Jia Li, MD

    Jia Li, MD

    Not yet recruiting

  • Xi'an Gaoxin Hospital

    Xi’an, Shanxi

    Ying Song, MD

    Ying Song, MD

    Not yet recruiting

  • Xingtai People's Hospital

    Xingtai, Hebei

    Qingge Zhang, MD

    Qingge Zhang, MD

    Not yet recruiting

  • The Third Hospital of Zhenjiang Affiliated Jiangsu University

    Zhenjiang, Jiangsu

    Youwen Tan, MD

    Youwen Tan, MD

    Not yet recruiting

Other trials in China

Thailand1 site, 1 recruiting

  • King Chulalongkorn Memorial Hospital affiliated to Chulalongkorn University

    Bangkok

    Sombat Treeprasertsuk, MD

    Sombat Treeprasertsuk, MD

    Not yet recruiting

Other trials in Thailand

Turkey (Türkiye)1 site, 1 recruiting

  • Ankara University School of Medicine

    Ankara

    Necati Örmeci, MD

    Necati Örmeci, MD

    Not yet recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Microbiome/Peptidome-based Model for Non-invasive Detection of High-risk Gastroesophageal Varices in Compensated Cirrhosis (CHESS1901/APPHA1901): A Prospective Multicenter Study

Variceal hemorrhage is a lethal complication in patients with cirrhosis and portal hypertension. Identification of varices needing treatment in compensated cirrhosis is, therefore, of great therapeutic and prognostic importance. The gold standard for diagnosing gastroesophageal varices and evaluating the risk of variceal hemorrhage is esophagogastroduodenoscopy. According to the Baveno VI consensus, for those with high-risk varices (HRV), either non-selective beta blockers or endoscopic band ligation is recommended for the prevention of the first variceal bleeding. However, the invasiveness and uncomfortableness during the esophagogastroduodenoscopy procedure has hindered its use in clinical practice, especially in patients with compensated cirrhosis. Sufficient accurate non-invasive tools for detection of HRV are warranted to safely avoid the use of esophagogastroduodenoscopy.

Advanced technologies including next-generation sequencing and MALDI-TOF mass spectrometry have the potential to be applied in this field. The latter is a widespread adopted tool in clinical microbiology for rapid, accurate and cost-effective identification of cultured bacteria and fungi. Recently, microbiome and peptidome have been proved their roles in the end-stage liver disease (e.g. cirrhosis, hepatocellular carcinoma), which may exhibit predictive capacity of HRV. In the present study, the investigators aim to conduct a prospective, multicenter diagnostic trial in 12 sites in China, 1 site in Turkey and 1 site in Thailand to evaluate the diagnostic performance of the microbiome/peptidome-based model for HRV detection in compensated cirrhosis.

Read the detailed description

Variceal hemorrhage is a lethal complication in patients with cirrhosis and portal hypertension. Identification of varices needing treatment in compensated cirrhosis is, therefore, of great therapeutic and prognostic importance. The gold standard for diagnosing gastroesophageal varices and evaluating the risk of variceal hemorrhage is esophagogastroduodenoscopy. According to the Baveno VI consensus, for those with high-risk varices (HRV), either non-selective beta blockers or endoscopic band ligation is recommended for the prevention of the first variceal bleeding. However, the invasiveness and uncomfortableness during the esophagogastroduodenoscopy procedure has hindered its use in clinical practice, especially in patients with compensated cirrhosis. Sufficient accurate non-invasive tools for detection of HRV are warranted to safely avoid the use of esophagogastroduodenoscopy.

Advanced technologies including next-generation sequencing and MALDI-TOF mass spectrometry have the potential to be applied in this field. The latter is a widespread adopted tool in clinical microbiology for rapid, accurate and cost-effective identification of cultured bacteria and fungi. Recently, microbiome and peptidome have been proved their roles in the end-stage liver disease (e.g. cirrhosis, hepatocellular carcinoma), which may exhibit predictive capacity of HRV. In the present study, the investigators aim to conduct a prospective, multicenter diagnostic trial in 12 sites (The First Hospital of Lanzhou University; Zhujiang Hospital of Southern Medical University; Nanfang Hospital of Southern Medical University; Xingtai People's Hospital; Zhongda Hospital, Medical School, Southeast University; The Third People's Hospital affiliated to Jiangsu University; Guangdong Second Provincial General Hospital; Tianjin Infectious Disease Hospital; Lishui Municipal Central Hospital; The Second Hospital of Anhui Medical University; Xi'an Gaoxin Hospital; The Sixth People's Hospital of Shenyang) in China, 1 site (Ankara University School of Medicine) in Turkey and 1 site (King Chulalongkorn Memorial Hospital affiliated to Chulalongkorn University) in Thailand to evaluate the diagnostic performance of the microbiome/peptidome-based model for HRV detection in compensated cirrhosis.

Being tested
esophagogastroduodenoscopy
Keywords
Microbiome/Peptidome, High-risk Gastroesophageal Varices, Compensated Cirrhosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • esophagogastroduodenoscopyDiagnostic test

    standard esophagogastroduodenoscopy

Study groups in NCT03990753
Study groupRoleWhat they receive
Overall eligible participantsEligible participants will receive standard esophagogastroduodenoscopy and microbiome/peptidome examination.
Receives: Diagnostic Test: esophagogastroduodenoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnostic performance of microbiome/peptidome-based model for high-risk varices

    Diagnostic performance of microbiome/peptidome-based model to determine the presence or absence of high-risk varices when compared with esophagogastroduodenoscopy as the reference standard

    Measured: 1 day

Secondary outcomes (2)

  1. Diagnostic performance of microbiome/peptidome-based model for decompensation or death

    Diagnostic performance of microbiome/peptidome-based model to determine the presence or absence of decompensation (defined as development of ascites, bleeding, or overt encephalopathy) or death within 3-year follow-up

    Measured: 3 years

  2. Diagnostic performance of microbiome/peptidome-based model for hepatic venous pressure gradient

    Diagnostic performance of microbiome/peptidome-based model to determine the level of hepatic venous pressure gradient

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2019
  2. Study start13 Jun 2019
  3. Primary completion12 Jun 2021
  4. Study completion12 Jun 2022 (estimated)

Resources

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
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03990753
Sponsor's protocol ID
CHESS1901
Status last verified
Aug 2021
First submitted
16 Jun 2019
Last updated
17 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Qi X, Berzigotti A, Cardenas A, Sarin SK. Emerging non-invasive approaches for diagnosis and monitoring of portal hypertension. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):708-719. doi: 10.1016/S2468-1253(18)30232-2.

    PubMed 30215362

  • He Y, Wu W, Zheng HM, Li P, McDonald D, Sheng HF, Chen MX, Chen ZH, Ji GY, Zheng ZD, Mujagond P, Chen XJ, Rong ZH, Chen P, Lyu LY, Wang X, Wu CB, Yu N, Xu YJ, Yin J, Raes J, Knight R, Ma WJ, Zhou HW. Regional variation limits applications of healthy gut microbiome reference ranges and disease models. Nat Med. 2018 Oct;24(10):1532-1535. doi: 10.1038/s41591-018-0164-x. Epub 2018 Aug 27.

    PubMed 30150716

  • Qi X, Li Z, Huang J, Zhu Y, Liu H, Zhou F, Liu C, Xiao C, Dong J, Zhao Y, Xu M, Xing S, Xu W, Yang C. Virtual portal pressure gradient from anatomic CT angiography. Gut. 2015 Jun;64(6):1004-5. doi: 10.1136/gutjnl-2014-308543. Epub 2014 Nov 14. No abstract available.

    PubMed 25398771

  • Qi X, An W, Liu F, Qi R, Wang L, Liu Y, Liu C, Xiang Y, Hui J, Liu Z, Qi X, Liu C, Peng B, Ding H, Yang Y, He X, Hou J, Tian J, Li Z. Virtual Hepatic Venous Pressure Gradient with CT Angiography (CHESS 1601): A Prospective Multicenter Study for the Noninvasive Diagnosis of Portal Hypertension. Radiology. 2019 Feb;290(2):370-377. doi: 10.1148/radiol.2018180425. Epub 2018 Nov 20.

    PubMed 30457484

  • 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.

    PubMed 30268833

  • Wang FS, Fan JG, Zhang Z, Gao B, Wang HY. The global burden of liver disease: the major impact of China. Hepatology. 2014 Dec;60(6):2099-108. doi: 10.1002/hep.27406. Epub 2014 Oct 29.

    PubMed 25164003

  • Garcia-Lezana T, Raurell I, Bravo M, Torres-Arauz M, Salcedo MT, Santiago A, Schoenenberger A, Manichanh C, Genesca J, Martell M, Augustin S. Restoration of a healthy intestinal microbiota normalizes portal hypertension in a rat model of nonalcoholic steatohepatitis. Hepatology. 2018 Apr;67(4):1485-1498. doi: 10.1002/hep.29646. Epub 2018 Feb 19.

    PubMed 29113028

  • Hoyles L, Fernandez-Real JM, Federici M, Serino M, Abbott J, Charpentier J, Heymes C, Luque JL, Anthony E, Barton RH, Chilloux J, Myridakis A, Martinez-Gili L, Moreno-Navarrete JM, Benhamed F, Azalbert V, Blasco-Baque V, Puig J, Xifra G, Ricart W, Tomlinson C, Woodbridge M, Cardellini M, Davato F, Cardolini I, Porzio O, Gentileschi P, Lopez F, Foufelle F, Butcher SA, Holmes E, Nicholson JK, Postic C, Burcelin R, Dumas ME. Molecular phenomics and metagenomics of hepatic steatosis in non-diabetic obese women. Nat Med. 2018 Jul;24(7):1070-1080. doi: 10.1038/s41591-018-0061-3. Epub 2018 Jun 25.

    PubMed 29942096

  • de Franchis R; Baveno VI Faculty. Expanding consensus in portal hypertension: Report of the Baveno VI Consensus Workshop: Stratifying risk and individualizing care for portal hypertension. J Hepatol. 2015 Sep;63(3):743-52. doi: 10.1016/j.jhep.2015.05.022. Epub 2015 Jun 3. No abstract available.

    PubMed 26047908

  • Garcia-Tsao G, Abraldes JG, Berzigotti A, Bosch J. Portal hypertensive bleeding in cirrhosis: Risk stratification, diagnosis, and management: 2016 practice guidance by the American Association for the study of liver diseases. Hepatology. 2017 Jan;65(1):310-335. doi: 10.1002/hep.28906. Epub 2016 Dec 1. No abstract available.

    PubMed 27786365

Questions about this trial

What is this clinical trial studying?

An observational study of Compensated Cirrhosis, run by Nanfang Hospital, Southern Medical University at 14 sites in 3 countries.

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 6 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: status not confirmed, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in China, Thailand, Turkey (Türkiye). 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xiaolong Qi, MD (+8618588602600, qixiaolong@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic performance of microbiome/peptidome-based model for high-risk varices (time frame: 1 day). 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 NCT03990753, which also lists 10 linked publications.

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 17 Aug 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in