CompletedNot Applicable

Sinusoidal Obstruction Syndrome for Stem Cell Transplant Patients Biomarker Study

United States80 participantsStarted 2017-04-01

Plain-language summary

The goal of this is to learn more about stem cell transplant and complications that some people have after their transplants, in particular sinusoidal obstruction syndrome (SOS), also called veno-occlusive disease of the liver.

Who can participate

Age range

25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. History of hepatic disease as defined by:
. Viral hepatitis (i.e., hepatitis C virus \[HCV\])
. Liver tumor before HCT
. Hepatic fibrosis or cirrhosis before HCT as proven by liver biopsy
. High aspartate aminotransferase (AST) (\> 2x ULN) before HCT (pre-transplant evaluation)
. High alanine transaminase (ALT) (\> 2x ULN) before HCT
. High bilirubin (\> 1.2x ULN) before HCT
. HCT high-risk features including:

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

SOS proteomic markers

Timeframe: Until the end of the study evaluation, day 180

Trial details

NCT IDNCT03132337

SponsorIndiana University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-01-14

View on ClinicalTrials.gov More Sinusoidal Obstruction Syndrome trials