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| ID | Type | Description | Link |
|---|---|---|---|
| 91-DK-0214 |
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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.
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
To determine if genetic factors may contribute to the susceptibility, progression, outcome, or treatment success of different liver diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy individuals | Healthy individuals who have recovered from liver diseases or who are healthy volunteers | ||
| Patients | Liver disease patients |
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| Measure | Description | Time Frame |
|---|---|---|
| Predisposition and outcomes related to liver disease susceptibility, progression, and treatment response | Predisposition and outcomes related to liver disease susceptibility, progression, and treatment response | Annual visits |
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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:
Healthy Volunteers
In order to be eligible to participate in this study, a healthy volunteer must meet all of the following criteria:
EXCLUSION CRITERIA:
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:
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This is a general clinical research protocol to allow for evaluation, investigation and long-term follow up of patients who have an acute or chronic liver disease. The protocol is designed 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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patricia E Alcivar | Contact | (301) 435-6121 | patricia.alcivar@nih.gov | |
| T. Jake Liang, M.D. | Contact | (301) 496-1721 | jakel@mail.nih.gov |
| Name | Affiliation | Role |
|---|---|---|
| T. Jake Liang, M.D. | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Recruiting | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31407130 | Derived | Ali RO, Moon MS, Townsend EC, Hill K, Zhang GY, Bradshaw A, Guan H, Hamilton D, Kleiner DE, Auh S, Koh C, Heller T. Exploring the Link Between Platelet Numbers and Vascular Homeostasis Across Early and Late Stages of Fibrosis in Hepatitis C. Dig Dis Sci. 2020 Feb;65(2):524-533. doi: 10.1007/s10620-019-05760-x. Epub 2019 Aug 12. | |
| 30664876 |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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| ID | Term |
|---|---|
| D003699 | Hepatitis D |
| D006526 | Hepatitis C |
| D006509 | Hepatitis B |
| D008107 | Liver Diseases |
| D006521 | Hepatitis, Chronic |
| ID | Term |
|---|---|
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D012327 | RNA Virus Infections |
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| Kefalakes H, Koh C, Sidney J, Amanakis G, Sette A, Heller T, Rehermann B. Hepatitis D Virus-Specific CD8+ T Cells Have a Memory-Like Phenotype Associated With Viral Immune Escape in Patients With Chronic Hepatitis D Virus Infection. Gastroenterology. 2019 May;156(6):1805-1819.e9. doi: 10.1053/j.gastro.2019.01.035. Epub 2019 Jan 18. |
| 23828202 | Derived | Koh C, Turner T, Zhao X, Minniti CP, Feld JJ, Simpson J, Demino M, Conrey AK, Jackson MJ, Seamon C, Kleiner DE, Kato GJ, Heller T. Liver stiffness increases acutely during sickle cell vaso-occlusive crisis. Am J Hematol. 2013 Nov;88(11):E250-4. doi: 10.1002/ajh.23532. Epub 2013 Aug 1. |
| D006505 |
| Hepatitis |
| D004066 | Digestive System Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D018178 | Flaviviridae Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |