Alcoholic Liver DiseaseSCALENCT03295812
Stratification of Chronic Alcoholic Liver Diseases (SCALE Study)
An observational study of Alcoholic Liver Disease, run by Nanfang Hospital, Southern Medical University at 26 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Alcoholic Liver Disease
- What is being tested?
- standard therapy
- How many people
- 3,000 participants
- Where
- 26 sitesChina
- Study dates
- 16 Nov 2017to 30 Dec 2020
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be selected from all in-patients in 24 hepatology departments
Who may be able to join
- Long-term alcohol consumption (at least one of the followings):
- >40g/d for male and >20g/d for female, at least for 5 years;
- >50g/d for at least 6 months;
- Liver injury (at least one of the followings):
- AST>1.0 ULN and AST>ALT;
- TBIL>2.0mg/dl;
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- Ascites;
- Hepatic encephalopathy;
- Esophageal variceal bleeding;
- Hypersplenism
Who cannot join
- Younger than 18 or older than 80;
- Other etiologies rather than alcoholic liver disease, including but not limited to the followings:
- Acute or chronic virologic hepatitis: Hepatitis A-E, Hepatitis caused by CMV,EBV, etc.
- Autoimmune hepatitis, including PSC, PBC, AIH, IgG4 related liver disease
- Inherited metabolic liver diseases: Wilson disease;
- Others: Schistosomiasis
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- HIV antibody positive;
- Malignancies including but not limited to HCC;
- Pregnancy;
- Hospital stay less than 24h;
- Refuse to sigh the informed consent;
- Combined with other improper situations determined by investigators.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
China26 sites, 14 recruiting
- Active, not recruiting
Dongguan dalang hospital
Dongguan
- Recruiting
People's hospital of Foshan Nanhai District
Foshan
Yan Chen
cchenyan_2005@163.com
- Recruiting
The First People's Hospital of Foshan
Foshan
Lixian Wu, 546245868@qq.com
- Recruiting
Nanfang Hospital
Guangzhou, Guangdong, 510515
Jinjun Chen, +8615521287260, chjj@smu.edu.cn
Tingting Qi, +8615521287260, tingtingqi@126.com
- Active, not recruiting
Guangdong General Hospital
Guangzhou
- Active, not recruiting
Guangzhou Eighth People's Hospital
Guangzhou
- Active, not recruiting
The First Affiliated Hospital,Guangzhou University of Chinese Medicine
Guangzhou
- Active, not recruiting
The First Affiliated Hospital,Jinan University
Guangzhou
- Recruiting
Huizhou Central Hospital
Huizhou
Zhanzhou Lin, lzz0752@21.cn.com
- Recruiting
Huizhou Hospital of Traditional Chinese Medicine
Huizhou
Xianhua Huang, hxhabm@163.com
- Recruiting
The First People's Hospital of Huizhou
Huizhou
Xiaohui Zhang, zhanjiang1007@163.com
- Recruiting
The Sixth People's Hospital of Huizhou
Huizhou
Gang Li, ligang636@163.com
- Recruiting
The Third People's hospital of Huizhou
Huizhou
Xuhui Li, lixuhui@126.com
- Not yet recruiting
People's Hospital of Enping
Jiangmen
Chongguang Zheng, 13929099567@139.com
- Active, not recruiting
Kaiping Central Hospital
Kaiping
- Active, not recruiting
People's hospital of Yangshan
Qingyuan, Guangdong
- Active, not recruiting
The Second People's Hospital of Yuebei
Shaoguan
- Recruiting
Peking University Shenzhen Hospital
Shenzhen
Jing Wu, W567jing@163.com
- Active, not recruiting
Shenzhen Third People's Hospital
Shenzhen
- Recruiting
Shunde Hospital of Southern Medical University
Shunde
Peng Wang, 1962wangpeng@163.com
- Active, not recruiting
Yangjiang Public Health Hospital
Yangjiang
- Recruiting
People's Hospital of Yingde City
Yingde
liangmin An, 542868087@qq.com
- Not yet recruiting
Nongken Central Hospital
Zhanjiang
Tengqing Li, gdsnkyyxhnkltq@tom.com
- Active, not recruiting
The First People's Hospital of Zhaoqing
Zhaoqing
- Active, not recruiting
Zhaoqing No.2 People's Hospital
Zhaoqing
- Recruiting
Zhongshan Second People's Hospital
Zhongshan
Wenjun Gao, gaowenjun888@163.com
About this study
Official title: 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.
- Conditions
- Alcoholic Liver Disease
- Being tested
- standard therapy
- Medical subject headings
- Liver Diseases, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard therapyOther
standard therapy,non-interventional study
What is being measured
The primary outcome is the main question the study is designed to answer.
4-week mortality
mortality rate
Measured: 4 weeks
12-week mortality
mortality rate
Measured: 12 weeks
Secondary outcomes (3)
4-week progression rate
The proportion of subjects progressed to acute-on-chronic liver failure within 4 weeks
Measured: 4 weeks
24-week mortality
mortality rate
Measured: 24 weeks
48-week mortality
mortality rate
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start16 Nov 2017
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jinjun Chen, Principal investigator, Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295812
- Sponsor's protocol ID
- 004
- Acronym
- SCALE
- Status last verified
- Sep 2017
- First submitted
- 25 Sep 2017
- Last updated
- 23 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stratification of Chronic Alcoholic Liver Diseases (SCALE Study) Based on Organs Injury: a Multi-center Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03295812
- Acronym / sponsor ID
- SCALE / 004
- Conditions
- Alcoholic Liver Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 16 Nov 2017 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 28 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be selected from all in-patients in 24 hepatology departments
Key inclusion criteria (10 listed)
- Long-term alcohol consumption (at least one of the followings):
- Liver injury (at least one of the followings):
Key exclusion criteria (12 listed)
- Younger than 18 or older than 80;
- Other etiologies rather than alcoholic liver disease, including but not limited to the followings:
- HIV antibody positive;
- Malignancies including but not limited to HCC;
- Pregnancy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard therapystandard therapy,non-interventional study | Other | – |
Primary outcome
4-week mortality
Time frame: 4 weeks
mortality rate
12-week mortality
Time frame: 12 weeks
mortality rate
3 secondary outcomes
4-week progression rate
Time frame: 4 weeks
24-week mortality
Time frame: 24 weeks
48-week mortality
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinjun Chen principal investigator
Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcoholic Liver Disease, run by Nanfang Hospital, Southern Medical University at 26 sites in China.
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 10 inclusion and 12 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 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in China. 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 Jinjun Chen (0086-18588531001, chjj@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
4-week mortality (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2018.