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临床试验/NCT03224949
NCT03224949招募中不适用

Comparison of ALD, NASH, and Healthy Control Patients

The Cleveland Clinic2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2017年6月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
2
主要终点
Biorepository

研究概览

简要总结

The availability of biological samples from individuals with alcoholic liver disease (ALD), as well as samples from appropriate heavy drinking, yet healthy controls and non-drinking healthy controls, is an essential first step in the translation of basic research advances to the clinic. The purpose of the Clinical Core component of the P50 Northern Ohio Alcohol Center (NOAC) is to provide biological samples (plasma/serum, buffy coats, and urine) from patients with different stages of alcoholic liver disease, as well as healthy control subjects, to members of the NOAC. These samples can then be used to test specific hypotheses related to the presence of specific biomarkers in the serum, functional immune activity in PBMCs and/or genetic polymorphisms that may predict severity of disease, short- and long-term morbidity and mortality and/or responsivity to specific therapeutic interventions commonly used in clinical practice. This study is building on the established biorepositories and the diversity of outstanding clinical expertise at the Cleveland Clinic. This biorepository included clinical samples (plasma, serum, buffy coats, and urine) from patients with different stages of ALD and subjects who are heavy drinkers without ALD, recruited from the Cleveland Clinic alcohol use disorder treatment clinic. This study will be responsible for collecting more data to help build the CCF-ALD biorepository via subject recruitment and communication and specimen collection.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Alcoholic Steatosis Patients
  • •Fat accumulation (Steatosis) without signs of fibrosis/ inflammation in patients with alcohol abuse (alcohol intake >60 g/day in men and >40 g/day in women)
  • •Abnormal liver serum tests indicative of liver disease (elevated AST>ALT, y-glutamyl transpeptidase and bilirubin) .
  • •Alcoholic Hepatitis with Mild Fibrosis
  • •Steatosis plus hepatocellular damage (presence of Mallory bodies and hepatocellular ballooning)
  • •Polymorphonuclear infiltrate
  • •Fibrosis stage 1-2
  • •Alcoholic Hepatitis with Advanced Fibrosis
  • •Steatosis plus hepatocellular damage (presence of Mallory bodies and hepatocellular ballooning)
  • •Polymorphonuclear infiltrate
  • •Fibrosis stage 3-
  • •Alcoholic Cirrhosis
  • •Fibrosis stage 4
  • •Presence of complications of cirrhosis such as esophageal varices with our without a previous episode of bleeding, splenomegaly, ascites, hepatic corroborate the diagnosis of cirrhosis.
  • •Alcoholic Cirrhosis with HCC
  • •Diagnostic criteria of cirrhosis and established HCC. The diagnosis of HCC will be established based on histological confirmation or contrast-enhanced radiographic imaging according to the AASLD recommendations.
  • •Hemochromatosis
  • •Wilson's disease
  • •Autoimmune hepatitis
  • •Drug-inducted liver disease
  • •Hepatitis C
  • •Antitrypsin deficiency
  • •Patients who do not sign informed consent.
  • •Non-alcoholic steatohepatitis
  • •Inclusion -Biopsy proven NASH and chronic liver disease due to HCV patients.
  • •Hypertension
  • •CAD or stroke
  • •Past history of liver disease
  • •Hepatitis C
  • •Antitrypsin deficiency
  • •Alcohol consumption of less than 7 drinks per week for women and less than 14 drinks per week for men
  • •Healthy controls
  • •AUDIT-C score less than 4 in men and less than 3 in women.
  • •Cancer (except of non-melanoma skin cancer)
  • •Hypertension
  • •Hypercholesterolemia
  • •Coronary artery disease or stroke
  • •History of current or past liver disease of any etiology
  • •BMI >27Kg/m2

排除标准

  • 未提供

研究组 & 干预措施

Alcoholic cirrhosis with HCC

干预措施: Blood draw (Other)

Healthy controls

干预措施: Blood draw (Other)

Alcoholic hepatitis

干预措施: Blood draw (Other)

Alcoholic steatosis

干预措施: Blood draw (Other)

Alcoholic cirrhosis without HCC

干预措施: Blood draw (Other)

Nonalcoholic steatohepatitis (NASH)

干预措施: Blood draw (Other)

结局指标

主要结局

Biorepository

时间窗: This is a 5 year study

The goal of this study is to create a biorepository of samples from patients with different types of liver disease compared to each other and healthy controls

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Srinivasan Dasarathy

Staff Physician

The Cleveland Clinic

研究点 (2)

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