Protocol Details
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant: A Prospective Natural History Study
This study is NOT currently recruiting participants.
Summary
Number | 000545-DK |
Sponsoring Institute | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Recruitment Detail | Type: Recruitment has not started
Gender: Male & Female
Min Age: 3 Years
Max Age: N/A |
Referral Letter Required | No |
Population Exclusion(s) | None |
Keywords | Liver Disease;
Liver Dysfunction;
Natural History |
Recruitment Keyword(s) | None |
Condition(s) | Hematopoietic Stem Cell Transplant |
Investigational Drug(s) | None |
Investigational Device(s) | None |
Intervention(s) | None |
Supporting Site | National Institute of Diabetes and Digestive and Kidney Diseases |
Background:
Hematopoietic stem cell transplant (HSCT) is a common treatment for many cancers and other illnesses. But many people who have HSCT go on to develop liver dysfunction. Researchers want to know more about how and why this happens. In this natural history study, they will try to learn what factors lead to liver dysfunction; how underlying liver disease may affect the results of HSCT; and how HSCT may contribute to liver dysfunction.
Objective:
To understand the links between HSCT and liver dysfunction.
Eligibility:
Adults aged 18 years or older and children 3 to 17 years who are being evaluated for HSCT.
Design:
This study involves 11 visits in 4 years. Most visits will be in the first year.
Before and after their HSCT, participants will undergo these tests:
Physical exam, including blood tests and a test of heart function. Participants will provide stool samples.
Liver biopsies. Samples of liver tissue will be removed. This may be done either by inserting a needle through the right side of the chest, or with a thin tube threaded to the liver from a vein in the neck. Adult participants will undergo this procedure 2 times: once before the HSCT and once about a year later.
Imaging scans. Participants will lie on a bed that moves into either a cylinder or a donut-shaped machine.
Ultrasound. Participants will lie still. A probe that uses sound waves will be slid over their skin to get pictures of the liver.
Fibroscan exam. This is like an ultrasound that uses a special probe to measure the toughness of the liver.
Eligibility
INCLUSION CRITERIA:
An individual who meets any of the following criteria will be included in this study:
-Male and female adults >=18 years of age and children 3-17 years of age
-Undergoing evaluation for hematopoietic stem cell transplant at the NIH Clinical Center
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this
study:
-Pregnancy or lactation
-Unable to comply with study procedures
-Inability to provide written informed consent
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT05722210