Using Ultrasound Elastography to Predict Development of Hepatic Sinusoidal Obstruction Syndrome (NCT03865589) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Using Ultrasound Elastography to Predict Development of Hepatic Sinusoidal Obstruction Syndrome
United States250 participantsStarted 2019-04-01
Plain-language 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).
Who can participate
Age range
1 Month – 99 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:
* Any patient undergoing a myeloablative conditioning regimen for HCT between 3/1/2019 and 12/31/2025 defined as one of the following:
* TBI \>= 1200 cGy (fractionated)
* Cyclophosphamide + TBI (\> 500 cGy (single) or \> 800cGy (fractionated))
* Cyclophosphamide + Etoposide + TBI (\> 500 cGy (single) or \> 800 cGy (fractionated))
* Cyclophosphamide + Thiotepa + TBI (\> 500 cGy (single) or \> 800 cGy (fractionated))
* Busulfan (Total dose \> 7.2 mg/kg IV or \>9.0mg/kg orally) + Cyclophosphamide
* Busulfan (Total dose \>7.2 mg/kg IV or \>9.0 mg/kg orally) + Melphalan
* Busulfan (Total dose \>7.2 mg/kg IV or \>9.0 mg/kg orally) + Thiotepa
* NOTE: Busulfan cumulative plasma AUC of \>75 mg/L per hour or \>18270 microMolar per minute could be used in the preceding criteria in lieu of the mg/kg doses.
OR
2\. Any patient who has a myeloablative conditioning regimen (as defined by the local HCT team) that includes sirolimus and tacrolimus for GVHD prophylaxis.
OR
3\. Any patient who is high risk for SOS irrespective of conditioning regimen: Neuroblastoma, HLH, Osteopetrosis, Thalassemia, treatment with inotuzumab or gemtuzumab within 3 months prior to HCT admission, 2nd HCT if it is myeloablative and within 6 months of prior, iron overload, steatohepatitis, active inflammatory or infection hepatitis or any other condition which puts the patient at a higher risk of developing SOS.
Subjects aged 1 month through 99 years will be eligible for the…
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
1
Define Sensitivity and Specificity Threshold for US SWE Risk