Stratification of Chronic Alcoholic Liver Diseases (SCALE Study) (SCALE)

January 19, 2018 updated by: Nanfang Hospital of Southern Medical University

Stratification of Chronic Alcoholic Liver Diseases (SCALE Study) Based on Organs Injury: a Multi-center Prospective Observational Study

Recent years, the European Association for the Study of the Liver-chronic liver failure (EASL-CLIF) has defined and graded acute-on-chronic liver failure (ACLF) based on CANONIC study which enrolled cirrhotic patients with acute decompensation. However, the characteristics and definitions of ACLF in non-cirrhotic patients with acute deterioration of liver function and organs injury or failure remain to be clear. As for patients who don't fulfil ACLF criteria, there might be a subgroup with high risk of progression (>25%) and a moderate 4-week mortality rate (>7%), which can be defined as "pre-ACLF", while the others are just chronic liver disease with "mere" liver injury or decompensation. This stratification system was primarily verified in a previous retrospective cohort which enrolled Hepatitis B patients only. The stratification criteria for chronic alcoholic liver disease needs to be further defined in detail. Therefore, investigators plan to prospectively recruit 3000 chronic alcoholic hospitalized patients with liver dysfunction from 24 hepatology departments in China, aiming to propose a stratified diagnostic system for chronic alcoholic patients based on organs injury. Meanwhile, risk factors of disease progression and short-term mortality will be analyzed, while characteristics and prognosis will be compared between patients with and without cirrhosis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3000

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Dongguan, China
        • Active, not recruiting
        • Dongguan dalang hospital
      • Foshan, China
        • Recruiting
        • The First People's Hospital of Foshan
        • Contact:
      • Foshan, China
      • Guangzhou, China
        • Active, not recruiting
        • Guangdong General Hospital
      • Guangzhou, China
        • Active, not recruiting
        • Guangzhou Eighth People's Hospital
      • Guangzhou, China
        • Active, not recruiting
        • The First Affiliated Hospital,Guangzhou University of Chinese Medicine
      • Guangzhou, China
        • Active, not recruiting
        • The First Affiliated Hospital,Jinan University
      • Huizhou, China
      • Huizhou, China
        • Recruiting
        • Huizhou Hospital of Traditional Chinese Medicine
        • Contact:
      • Huizhou, China
      • Huizhou, China
        • Recruiting
        • The Sixth People's Hospital of Huizhou
        • Contact:
      • Huizhou, China
        • Recruiting
        • The Third People's Hospital of Huizhou
        • Contact:
      • Jiangmen, China
        • Not yet recruiting
        • People's Hospital of Enping
        • Contact:
      • Kaiping, China
        • Active, not recruiting
        • Kaiping Central Hospital
      • Shaoguan, China
        • Active, not recruiting
        • The Second People's Hospital of Yuebei
      • Shenzhen, China
        • Recruiting
        • Peking University Shenzhen Hospital
        • Contact:
      • Shenzhen, China
        • Active, not recruiting
        • Shenzhen Third People's Hospital
      • Shunde, China
        • Recruiting
        • Shunde Hospital of Southern Medical University
        • Contact:
      • Yangjiang, China
        • Active, not recruiting
        • Yangjiang Public Health Hospital
      • Yingde, China
        • Recruiting
        • People's Hospital of Yingde City
        • Contact:
      • Zhanjiang, China
      • Zhaoqing, China
        • Active, not recruiting
        • The First People's Hospital of Zhaoqing
      • Zhaoqing, China
        • Active, not recruiting
        • Zhaoqing No.2 People's Hospital
      • Zhongshan, China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital
      • Qingyuan, Guangdong, China
        • Active, not recruiting
        • People's hospital of Yangshan

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients will be selected from all in-patients in 24 hepatology departments

Description

Inclusion Criteria:

  1. Long-term alcohol consumption (at least one of the followings):

    1. >40g/d for male and >20g/d for female, at least for 5 years;
    2. >50g/d for at least 6 months;

  2. Liver injury (at least one of the followings):

    1. AST>1.0 ULN and AST>ALT;
    2. TBIL>2.0mg/dl;
    3. Ascites;
    4. Hepatic encephalopathy;
    5. Esophageal variceal bleeding;
    6. Hypersplenism

Exclusion Criteria:

  1. Younger than 18 or older than 80;

  2. Other etiologies rather than alcoholic liver disease, including but not limited to the followings:

    1. Acute or chronic virologic hepatitis: Hepatitis A-E, Hepatitis caused by CMV,EBV, etc.
    2. Autoimmune hepatitis, including PSC, PBC, AIH, IgG4 related liver disease
    3. Inherited metabolic liver diseases: Wilson disease;
    4. Others: Schistosomiasis
  3. HIV antibody positive;
  4. Malignancies including but not limited to HCC;
  5. Pregnancy;
  6. Hospital stay less than 24h;
  7. Refuse to sigh the informed consent;
  8. Combined with other improper situations determined by investigators.

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
4-week mortality
Time Frame: 4 weeks
mortality rate
4 weeks
12-week mortality
Time Frame: 12 weeks
mortality rate
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
4-week progression rate
Time Frame: 4 weeks
The proportion of subjects progressed to acute-on-chronic liver failure within 4 weeks
4 weeks
24-week mortality
Time Frame: 24 weeks
mortality rate
24 weeks
48-week mortality
Time Frame: 48 weeks
mortality rate
48 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Risk factors for disease progression within 4 weeks
Time Frame: 4 weeks
analysis of risk factors for disease progression
4 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanfang Hospital of Southern Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jinjun Chen, Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 16, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 25, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 004

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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