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NCT03858530 · ClinicalTrials.gov registry record · NA
Ultrasound Elastography to Predict Development of SOS
A NA study, sponsored by Children's Mercy Hospital Kansas City.
- Terminated
- Registry status
- NA
- Development phase
- 21
- Enrollment target
NCT03858530: Clinical Trial NA study, sponsored by Children's Mercy Hospital Kansas City.
NCT03858530 is a NA study that was terminated before completion, run by Children's Mercy Hospital Kansas City. The registered enrollment target is 21 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03858530, a NA study, was terminated before completion, sponsored by Children's Mercy Hospital Kansas City.
- TERMINATED
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
Study Summary
The long-term goal of our research is to accurately identify SOS patients who would benefit from defibrotide treatment using US SWE. The overall objective of this study is to validate SWE as an early diagnostic marker for SOS. Our central hypothesis is that SWE changes will precede clinical and conventional US diagnostic criteria for SOS. Our hypothesis has been formulated on the basis of our own preliminary data. The investigators completed the first prospective cohort trial demonstrating that US SWE provides SOS diagnosis (80% sensitivity and 67% specificity) nine days earlier than current clinical criteria. SWE is widely available, has no known side effects, and is easy to learn and interpret. Our study enrolled 25 high-risk BMT patients over 18 months (five with SOS and two with severe SOS). More data is needed to determine the optimal window for testing to balance between improved test characteristics and early detection of disease. The investigators propose conducting a prospective cohort study with 80 additional patients, 12 of which will likely develop SOS (including four with severe SOS) to optimize SWE timing. This study will increase the confidence in the findings from our preliminary study and allow us to test SWE against newly published clinical criteria. The rationale for the proposed research is that, if SWE can diagnose SOS earlier than clinical criteria, then SWE can guide early initiation of SOS treatment.
Primary Outcome
We performed SWE exams once a week for all of our patients. We looked at when patients met clinical criteria for VOD/SOS and then we looked at the SWE exams that were performed before the clinical diagnosis. If the exam immediately preceding the date of clinical diagnosis crossed the threshold for SWE diagnosis, then a frequency of 7 days was sufficient. If it did not, then testing should be more frequent. If multiple preceding exams were positive by SWE, then the optimal testing frequency could
Interventions
- DIAGNOSTIC_TEST Ultrasound Examination
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2018-05-01 |
| Est. Completion | 2024-01-16 |
| Phase | NA |
Why NCT03858530 stopped before completion
NCT03858530 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Ultrasound Examination is the first listed.
NCT03858530 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03858530 about?
NCT03858530 is a clinical study titled "Ultrasound Elastography to Predict Development of SOS". The long-term goal of our research is to accurately identify SOS patients who would benefit from defibrotide treatment using US SWE. The overall objective of this study is to validate SWE as an early diagnostic marker for SOS. Our central hypothesis is that SWE changes will precede clinical and conv...
What is the current status of trial NCT03858530?
This trial is currently terminated. It is a NA study. The enrollment target is 21 participants. The study started on 2018-05-01. Estimated completion is 2024-01-16.
What interventions are being tested in trial NCT03858530?
The interventions under investigation include: Ultrasound Examination (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03858530?
This trial is sponsored by Children's Mercy Hospital Kansas City, which has 184 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03858530's enrollment target sits among peer trials
21 1762nd of 2000 higher than 233 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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