Evaluation of Patients With Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 8,050
- 试验地点
- 1
- 主要终点
- Predisposition and outcomes related to liver disease susceptibility, progression, and treatment response
研究概览
简要总结
The proposed study aims to evaluate, investigate, and follow-up patients suffering from acute and chronic liver disease. The study will focus on understanding diseases affecting the liver.
Patients participating in the study will first undergo a routine check-up as an outpatient. They will be asked to provide blood and urine samples for laboratory testing and will undergo an ultrasound of the liver. Ultrasound examinations use sound waves to determine the size and texture of the liver. After the initial visit subjects will be requested to follow-up once a year at the outpatient department for a similar check-up.
Additional tests may be requested throughout the study to provide information for other research studies and individual consent will be requested. These tests may include liver biopsies, skin biopsies, and / or specialized blood, plasma, and lymphocyte examinations.
Subjects that qualify for medications presently being studied may be offered the opportunity to benefit from experimental therapy.
详细描述
Study Description:
This is a clinical research protocol to allow for collection of samples and data obtained during clinical evaluation and long-term follow up of patients who have an acute or chronic liver disease. The protocol is designed to create a repository to study the natural history and pathogenesis of various liver diseases such as acute and chronic hepatitis B, C, D and E, primary biliary cirrhosis, primary sclerosing cholangitis, Wilson's disease, hemochromatosis, nonalcoholic steatohepatitis (NASH), noncirrhotic portal hypertension, hepatocellular carcinoma, and cryptogenic or poorly defined forms of chronic liver disease. Samples collected during the course of clinical care for patients with liver disease include blood, saliva, urine, stool, and residual tissue obtained during clinically-indicated liver biopsies not otherwise needed for clinical care. Additionally, subjects with liver disease will be asked to provide a blood sample for genetic analysis. Healthy volunteers will be recruited and asked to provide a blood sample to serve as controls for the genetic analyses. Research will be conducted to investigate genetic factors that may contribute to liver diseases
Objectives: Primary Objective
To collect data and samples during clinical evaluation, treatment and follow-up of participants for future use in studies of liver diseases
Secondary Objective
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •INCLUSION CRITERIA:
- •Affected Subjects
- •In order to be eligible to participate in this study, an affected participant must meet all of the following criteria:
- •>=2 years of age.
- •Meets one of the following:
- •Suspected or evidence of acute or chronic liver disease on evaluation by a referring licensed independent practitioner (LIP), OR
- •At risk for acute or chronic liver disease
- •Healthy Volunteers
- •In order to be eligible to participate in this study, a healthy volunteer must meet all of the following criteria:
- •>= 18 years of age.
- •In good general health as evidenced by medical history
排除标准
- •Affected Participants
- •An affected participant who meets any of the following criteria will be excluded from participation in this study:
- •1. History of significant medical illnesses that might interfere with prolonged follow up evaluation
- •Healthy Volunteers
- •A healthy volunteer who meets any of the following criteria will be excluded from participation in this study:
- •Any chronic medical condition, including (but not limited to) heart, kidney, or lung diseases
- •Taking any regular medications or supplements (with the exception of regular multivitamins and/or oral contraceptives)
- •Average alcohol consumption > 1 drink/day in past 6 months, per self-report
- •History of liver disease (with the exception of neonatal jaundice)
- •History of severe illness, infection or major surgery in the past year
- •History of cancer (with the exception of basal cell carcinoma resected > 1 year prior to enrollment)
- •BMI < 18 or BMI >25
- •Hemoglobin < 11 (women) or hemoglobin < 12 (men)
- •ALT >35 (men) or ALT >25 (women)
- •Alkaline Phosphatase >= 150
- •Bilirubin >2 g/dL
- •HIV positive, Anti-HCV positive, HBsAg positive or Anti-HBc positive
- •Inability to provide informed consent
研究组 & 干预措施
Healthy individuals
Healthy individuals who have recovered from liver diseases or who are healthy volunteers
Patients
Liver disease patients
结局指标
主要结局
Predisposition and outcomes related to liver disease susceptibility, progression, and treatment response
时间窗: Annual visits
Predisposition and outcomes related to liver disease susceptibility, progression, and treatment response
次要结局
未报告次要终点