Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-90
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

About this trial

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.

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Eligibility criteria

Qualifiers

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

Disqualifiers

Pregnancy or lactation

Unable to comply with study procedures

Inability to provide written informed consent

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

500 Participants
are grouped into 2 trial groups