Status:
ACTIVE_NOT_RECRUITING
Using Ultrasound Elastography to Predict Development of Hepatic Sinusoidal Obstruction Syndrome
Lead Sponsor:
Children's Mercy Hospital Kansas City
Collaborating Sponsors:
Jazz Pharmaceuticals
Nationwide Children's Hospital
Conditions:
Bone Marrow Transplant Complications
Sinusoidal Obstruction Syndrome
Eligibility:
All Genders
1-99 years
Phase:
NA
Brief 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 d...
Detailed Description
Hepatic sinusoidal obstructive syndrome (SOS), also known as veno-occlusive disease, is a complication of hematopoietic stem cell transplant (HCT) that is associated with high morbidity and mortality....
Eligibility Criteria
Inclusion
- 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 study. Patients who receive defibrotide and/or ursodiol for VOD/SOS prophylaxis will also be eligible for the study. At most 175 children (ages 1 month to 18 years) and 175 adults (\>18 years old) can be enrolled into the study.
- Inclusion dates: Patients seen between 1/1/2019 and 12/31/2025
Exclusion
- Any patient who has contraindication to ultrasound shear wave elastography (e.g. unable to hold still) Adults unable to consent Pregnant women Prisoners Wards of the state
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2027
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT03865589
Start Date
April 1 2019
End Date
June 30 2027
Last Update
January 8 2026
Active Locations (7)
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1
University of California, San Francisco
San Francisco, California, United States, 94143
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
3
Children's Mercy
Kansas City, Missouri, United States, 64108
4
Duke University
Durham, North Carolina, United States, 27705