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Ultrasound Elastography for Predicting Sinusoidal Obstruction Syndrome

N/A
Recruiting
Led By Sherwin S Chan, MD, PhD
Research Sponsored by Children's Mercy Hospital Kansas City
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Any patient who is high risk for SOS irrespective of conditioning regimen, including specific high-risk conditions and recent treatments
Any patient who has a myeloablative conditioning regimen that includes sirolimus and tacrolimus for GVHD prophylaxis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 100 days post transplant
Awards & highlights

Study Summary

This trial is looking at using ultrasound to predict risk of a condition called sinusoidal obstruction syndrome (SOS) in people who have had a bone marrow transplant.

Who is the study for?
This trial is for patients undergoing intense pre-transplant treatment (myeloablative conditioning) for stem cell transplant, including those at high risk for liver-related complications post-transplant. It's not suitable for individuals who can't undergo ultrasound elastography due to conditions like an inability to remain still.Check my eligibility
What is being tested?
The study tests how well ultrasound elastography can predict and categorize the severity of a liver complication called Sinusoidal Obstruction Syndrome in bone marrow transplant patients. The goal is to establish a reliable method to identify patients' risks before severe symptoms develop.See study design
What are the potential side effects?
Ultrasound elastography itself is generally safe and non-invasive with minimal side effects; however, discomfort or minor pain from pressure during the procedure may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am at high risk for severe organ damage due to my condition or recent treatments.
Select...
I am receiving sirolimus and tacrolimus to prevent graft-versus-host disease.
Select...
I am scheduled for a strong chemotherapy or radiation therapy before a stem cell transplant between April 1, 2019, and December 31, 2120.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~100 days post transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 100 days post transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Define Sensitivity and Specificity Threshold for US SWE Risk
Secondary outcome measures
Quantify Temporal Relationship between SWE and SOS and Baltimore Criteria
Quantify Temporal Relationship between SWE and SOS and EBMT Consortium
Quantify Temporal Relationship between SWE and SOS and Modified Seattle Criteria

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients Undergoing HCTExperimental Treatment1 Intervention
All patients enrolled will undergo US SWE at specific time points as outlined in the protocol based on disease course.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ultrasound Elastography
2017
N/A
~70

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteOTHER
1,077 Previous Clinical Trials
340,493 Total Patients Enrolled
University of California, San FranciscoOTHER
2,496 Previous Clinical Trials
11,933,639 Total Patients Enrolled
University Hospitals Cleveland Medical CenterOTHER
317 Previous Clinical Trials
340,104 Total Patients Enrolled

Media Library

Ultrasound Elastography Clinical Trial Eligibility Overview. Trial Name: NCT03865589 — N/A
Sinusoidal Obstruction Syndrome Research Study Groups: Patients Undergoing HCT
Sinusoidal Obstruction Syndrome Clinical Trial 2023: Ultrasound Elastography Highlights & Side Effects. Trial Name: NCT03865589 — N/A
Ultrasound Elastography 2023 Treatment Timeline for Medical Study. Trial Name: NCT03865589 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age limit for recruitment into this investigation?

"This medical experiment is looking for individuals between 1 Month and 99 years of age."

Answered by AI

Are there any qualifications necessary to participate in this research?

"To be included in this medical study, participants must have veno occlusive disease of the liver and should fall between one month old to almost a century. The desired sample size is 250 individuals."

Answered by AI

Are there any opportunities for volunteer participants in this clinical experiment?

"Affirmative. The information on clinicaltrials.gov demonstrates the recruitment status of this study - initially posted in April 2019 and most recently updated in September 2022 - with a need for 250 participants from one medical centre."

Answered by AI

How many participants are needed for this clinical trial?

"Indeed, current records on clinicaltrials.gov verify that this medical trial commenced recruitment on April 1st 2019 and is actively seeking participants. The study has a goal of enrolling 250 patients from one single location."

Answered by AI
Recent research and studies
~66 spots leftby Dec 2025