<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03295812</url>
  </required_header>
  <id_info>
    <org_study_id>004</org_study_id>
    <nct_id>NCT03295812</nct_id>
  </id_info>
  <brief_title>Stratification of Chronic Alcoholic Liver Diseases (SCALE Study)</brief_title>
  <acronym>SCALE</acronym>
  <official_title>Stratification of Chronic Alcoholic Liver Diseases (SCALE Study) Based on Organs Injury: a Multi-center Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanfang Hospital, Southern Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanfang Hospital, Southern Medical University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recent years, the European Association for the Study of the Liver-chronic liver failure&#xD;
      (EASL-CLIF) has defined and graded acute-on-chronic liver failure (ACLF) based on CANONIC&#xD;
      study which enrolled cirrhotic patients with acute decompensation. However, the&#xD;
      characteristics and definitions of ACLF in non-cirrhotic patients with acute deterioration of&#xD;
      liver function and organs injury or failure remain to be clear. As for patients who don't&#xD;
      fulfil ACLF criteria, there might be a subgroup with high risk of progression (&gt;25%) and a&#xD;
      moderate 4-week mortality rate (&gt;7%), which can be defined as &quot;pre-ACLF&quot;, while the others&#xD;
      are just chronic liver disease with &quot;mere&quot; liver injury or decompensation. This&#xD;
      stratification system was primarily verified in a previous retrospective cohort which&#xD;
      enrolled Hepatitis B patients only. The stratification criteria for chronic alcoholic liver&#xD;
      disease needs to be further defined in detail. Therefore, investigators plan to prospectively&#xD;
      recruit 3000 chronic alcoholic hospitalized patients with liver dysfunction from 24&#xD;
      hepatology departments in China, aiming to propose a stratified diagnostic system for chronic&#xD;
      alcoholic patients based on organs injury. Meanwhile, risk factors of disease progression and&#xD;
      short-term mortality will be analyzed, while characteristics and prognosis will be compared&#xD;
      between patients with and without cirrhosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 16, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>4-week mortality</measure>
    <time_frame>4 weeks</time_frame>
    <description>mortality rate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>12-week mortality</measure>
    <time_frame>12 weeks</time_frame>
    <description>mortality rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>4-week progression rate</measure>
    <time_frame>4 weeks</time_frame>
    <description>The proportion of subjects progressed to acute-on-chronic liver failure within 4 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>24-week mortality</measure>
    <time_frame>24 weeks</time_frame>
    <description>mortality rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>48-week mortality</measure>
    <time_frame>48 weeks</time_frame>
    <description>mortality rate</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Risk factors for disease progression within 4 weeks</measure>
    <time_frame>4 weeks</time_frame>
    <description>analysis of risk factors for disease progression</description>
  </other_outcome>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Alcoholic Liver Disease</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>standard therapy</intervention_name>
    <description>standard therapy,non-interventional study</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma, serum, urine and DNA samples will be reserved&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients will be selected from all in-patients in 24 hepatology departments&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Long-term alcohol consumption (at least one of the followings):&#xD;
&#xD;
               1. &gt;40g/d for male and &gt;20g/d for female, at least for 5 years;&#xD;
&#xD;
               2. &gt;50g/d for at least 6 months;&#xD;
&#xD;
          2. Liver injury (at least one of the followings):&#xD;
&#xD;
               1. AST&gt;1.0 ULN and AST&gt;ALT;&#xD;
&#xD;
               2. TBIL&gt;2.0mg/dl;&#xD;
&#xD;
               3. Ascites;&#xD;
&#xD;
               4. Hepatic encephalopathy;&#xD;
&#xD;
               5. Esophageal variceal bleeding;&#xD;
&#xD;
               6. Hypersplenism&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Younger than 18 or older than 80;&#xD;
&#xD;
          2. Other etiologies rather than alcoholic liver disease, including but not limited to the&#xD;
             followings:&#xD;
&#xD;
               1. Acute or chronic virologic hepatitis: Hepatitis A-E, Hepatitis caused by CMV,EBV,&#xD;
                  etc.&#xD;
&#xD;
               2. Autoimmune hepatitis, including PSC, PBC, AIH, IgG4 related liver disease&#xD;
&#xD;
               3. Inherited metabolic liver diseases: Wilson disease;&#xD;
&#xD;
               4. Others: Schistosomiasis&#xD;
&#xD;
          3. HIV antibody positive;&#xD;
&#xD;
          4. Malignancies including but not limited to HCC;&#xD;
&#xD;
          5. Pregnancy;&#xD;
&#xD;
          6. Hospital stay less than 24h;&#xD;
&#xD;
          7. Refuse to sigh the informed consent;&#xD;
&#xD;
          8. Combined with other improper situations determined by investigators.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jinjun Chen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jinjun Chen</last_name>
    <phone>0086-18588531001</phone>
    <email>chjj@smu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tingting Qi</last_name>
    <phone>+8615521287260</phone>
    <email>tingtingqi@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Nanfang Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510515</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jinjun Chen</last_name>
      <phone>+8615521287260</phone>
      <email>chjj@smu.edu.cn</email>
    </contact>
    <contact_backup>
      <last_name>Tingting Qi</last_name>
      <phone>+8615521287260</phone>
      <email>tingtingqi@126.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>People's hospital of Yangshan</name>
      <address>
        <city>Qingyuan</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Dongguan dalang hospital</name>
      <address>
        <city>Dongguan</city>
        <country>China</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>People's hospital of Foshan Nanhai District</name>
      <address>
        <city>Foshan</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yan Chen</last_name>
    </contact>
    <contact_backup>
      <email>cchenyan_2005@163.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>The First People's Hospital of Foshan</name>
      <address>
        <city>Foshan</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lixian Wu</last_name>
      <email>546245868@qq.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Guangdong General Hospital</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Guangzhou Eighth People's Hospital</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital,Guangzhou University of Chinese Medicine</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital,Jinan University</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Huizhou Central Hospital</name>
      <address>
        <city>Huizhou</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhanzhou Lin</last_name>
      <email>lzz0752@21.cn.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Huizhou Hospital of Traditional Chinese Medicine</name>
      <address>
        <city>Huizhou</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xianhua Huang</last_name>
      <email>hxhabm@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First People's Hospital of Huizhou</name>
      <address>
        <city>Huizhou</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaohui Zhang</last_name>
      <email>zhanjiang1007@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Sixth People's Hospital of Huizhou</name>
      <address>
        <city>Huizhou</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gang Li</last_name>
      <email>ligang636@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Third People's hospital of Huizhou</name>
      <address>
        <city>Huizhou</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xuhui Li</last_name>
      <email>lixuhui@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>People's Hospital of Enping</name>
      <address>
        <city>Jiangmen</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Chongguang Zheng</last_name>
      <email>13929099567@139.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Kaiping Central Hospital</name>
      <address>
        <city>Kaiping</city>
        <country>China</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Second People's Hospital of Yuebei</name>
      <address>
        <city>Shaoguan</city>
        <country>China</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Peking University Shenzhen Hospital</name>
      <address>
        <city>Shenzhen</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jing Wu</last_name>
      <email>W567jing@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shenzhen Third People's Hospital</name>
      <address>
        <city>Shenzhen</city>
        <country>China</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Shunde Hospital of Southern Medical University</name>
      <address>
        <city>Shunde</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peng Wang</last_name>
      <email>1962wangpeng@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Yangjiang Public Health Hospital</name>
      <address>
        <city>Yangjiang</city>
        <country>China</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>People's Hospital of Yingde City</name>
      <address>
        <city>Yingde</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>liangmin An</last_name>
      <email>542868087@qq.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Nongken Central Hospital</name>
      <address>
        <city>Zhanjiang</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Tengqing Li</last_name>
      <email>gdsnkyyxhnkltq@tom.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First People's Hospital of Zhaoqing</name>
      <address>
        <city>Zhaoqing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Zhaoqing No.2 People's Hospital</name>
      <address>
        <city>Zhaoqing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Zhongshan Second People's Hospital</name>
      <address>
        <city>Zhongshan</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wenjun Gao</last_name>
      <email>gaowenjun888@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>January 19, 2018</last_update_submitted>
  <last_update_submitted_qc>January 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Liver Diseases, Alcoholic</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03295812
org study id: 004
nct id: NCT03295812
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Prospective
measure: 4-week mortality
time frame: 4 weeks
description: mortality rate
measure: 12-week mortality
time frame: 12 weeks
description: mortality rate
measure: 4-week progression rate
time frame: 4 weeks
description: The proportion of subjects progressed to acute-on-chronic liver failure within 4 weeks
measure: 24-week mortality
time frame: 24 weeks
description: mortality rate
measure: 48-week mortality
time frame: 48 weeks
description: mortality rate
measure: Risk factors for disease progression within 4 weeks
time frame: 4 weeks
description: analysis of risk factors for disease progression
intervention type: Other
intervention name: standard therapy
description: standard therapy,non-interventional study
Plasma, serum, urine and DNA samples will be reserved
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jinjun Chen
role: Principal Investigator
affiliation: Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University
last name: Jinjun Chen
phone: 0086-18588531001
email: chjj@smu.edu.cn
last name: Tingting Qi
phone: +8615521287260
email: tingtingqi@126.com
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Liver Diseases
mesh term: Liver Diseases, Alcoholic