Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001971
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2006-07-12
Brief Title:
Evaluation of Patients With Liver Disease
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluation of Patients With Liver Disease
Status:
RECRUITING
Status Verified Date:
2024-10-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 Wilsons 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
To determine if genetic factors may contribute to the susceptibility progression outcome or treatment success of different liver diseases
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 Wilsons 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
To determine if genetic factors may contribute to the susceptibility progression outcome or treatment success of different liver diseases
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 91-DK-0214 | None | None | None |