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Using Ultrasound Elastography to Predict Development of Hepatic Sinusoidal Obstruction Syndrome
NCT03865589 · View on ClinicalTrials.gov ↗
Study Summary
To perform an receiver operating characteristic (ROC) analysis, define a threshold and quantify the sensitivity and specificity of US SWE for risk stratification of patients into three categories as defined by the European Bone Marrow Transplant (EBMT) adult and pediatric criteria: no sinusoidal obstruction syndrome (SOS), mild to moderate SOS, and severe to very severe SOS. Secondarily, the investigators would also like to quantify the temporal relationship between US SWE changes and SOS diagnosis according to various clinical criteria (Modified Seattle, Baltimore, EBMT consortium).
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Ultrasound Elastography
Study Locations (7)
Ohio
- University Hospitals Cleveland Medical Center — Cleveland
- Nationwide Children's Hospital — Columbus
California
- University of California, San Francisco — San Francisco
Massachusetts
- Dana-Farber Cancer Institute — Boston
Missouri
- Children's Mercy — Kansas City
North Carolina
- Duke University — Durham
Tennessee
- St. Jude Children's Research Hospital — Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2019-04-01 |
| Est. Completion | 2027-06-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03865589
The ClinicalTrials.gov registry entry for NCT03865589 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Mercy Hospital Kansas City, which has 93 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Stem Cell Transplant Complications appearing as the primary indexed condition, and to 1 intervention — of which Ultrasound Elastography is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03865589 reports 7 study locations spanning 6 distinct geographic areas — top geographies include Ohio, California, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03865589 about?
NCT03865589 is a clinical study titled "Using Ultrasound Elastography to Predict Development of Hepatic Sinusoidal Obstruction Syndrome". To perform an receiver operating characteristic (ROC) analysis, define a threshold and quantify the sensitivity and specificity of US SWE for risk stratification of patients into three categories as defined by the European Bone Marrow Transplant (EBMT) adult and pediatric criteria: no sinusoidal obs...
What is the current status of trial NCT03865589?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 250 participants. The study started on 2019-04-01. Estimated completion is 2027-06-30.
What conditions does trial NCT03865589 study?
This clinical trial studies the following conditions: Stem Cell Transplant Complications, Bone Marrow Transplant Complications, Sinusoidal Obstruction Syndrome, Veno Occlusive Disease, Hepatic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03865589?
The interventions under investigation include: Ultrasound Elastography (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03865589?
This trial is sponsored by Children's Mercy Hospital Kansas City, which has 93 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03865589 being conducted?
This trial has 7 study locations across California, Massachusetts, Missouri, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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