ACTIVE_NOT_RECRUITING

Using Ultrasound Elastography to Predict Development of Hepatic Sinusoidal Obstruction Syndrome

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Conditions

Bone Marrow Transplant ComplicationsSinusoidal Obstruction SyndromeVeno Occlusive Disease, HepaticStem Cell Transplant ComplicationsUltrasound Elastography

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Using Ultrasound Elastography to Predict Development of Hepatic Sinusoidal Obstruction Syndrome

Quick Facts

Study Start:2019-04-01
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03865589

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Month to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Any patient undergoing a myeloablative conditioning regimen for HCT between 3/1/2019 and 12/31/2025 defined as one of the following:
  2. * TBI \>= 1200 cGy (fractionated)
  3. * Cyclophosphamide + TBI (\> 500 cGy (single) or \> 800cGy (fractionated))
  4. * Cyclophosphamide + Etoposide + TBI (\> 500 cGy (single) or \> 800 cGy (fractionated))
  5. * Cyclophosphamide + Thiotepa + TBI (\> 500 cGy (single) or \> 800 cGy (fractionated))
  6. * Busulfan (Total dose \> 7.2 mg/kg IV or \>9.0mg/kg orally) + Cyclophosphamide
  7. * Busulfan (Total dose \>7.2 mg/kg IV or \>9.0 mg/kg orally) + Melphalan
  8. * Busulfan (Total dose \>7.2 mg/kg IV or \>9.0 mg/kg orally) + Thiotepa
  9. * 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.
  10. 2. Any patient who has a myeloablative conditioning regimen (as defined by the local HCT team) that includes sirolimus and tacrolimus for GVHD prophylaxis.
  11. 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.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Sherwin S Chan, MD, PhD
PRINCIPAL_INVESTIGATOR
Children's Mercy Hospital Kansas City

Study Locations (Sites)

University of California, San Francisco
San Francisco, California, 94143
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Children's Mercy
Kansas City, Missouri, 64108
United States
Duke University
Durham, North Carolina, 27705
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
United States

Collaborators and Investigators

Sponsor: Children's Mercy Hospital Kansas City

  • Sherwin S Chan, MD, PhD, PRINCIPAL_INVESTIGATOR, Children's Mercy Hospital Kansas City

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-04-01
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2019-04-01
Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

  • Ultrasound Elastography

Additional Relevant MeSH Terms

  • Bone Marrow Transplant Complications
  • Sinusoidal Obstruction Syndrome
  • Veno Occlusive Disease, Hepatic
  • Stem Cell Transplant Complications