A Prospective Registry of Pediatric Cellular Therapy Patients at Risk for Endothelial Dysfunction, Sinusoidal Obstruction Syndrome and/or Multi-Organ Dysfunction Syndrome (MODS).

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Duke University
Study ID
NCT05090345
Status
Recruiting
Apply to this trial

Conditions

  • Hematopoietic Cell Transplantation

Eligibility Criteria

Sex
ALL
Age
0 Years - 26 Years
Healthy Volunteers
Not accepted

Interventions

  • Biorepository Trial — OTHER
    participating in this arm, peripheral blood specimen(s) will be obtained at 8 specified time-points.

Study Details

This is a prospective international multi-center registry and biorepository trial of children and adolescents/young adults (AYA) undergoing hematopoietic cell transplantation (HCT) to assess the impact of endotheliopathies in the HCT setting as a contributor of significant morbidity and mortality.

Key Dates

Start date
Nov 19, 2019
Status verified
May 2026
Primary completion
Feb 5, 2027
Completion
Feb 5, 2028

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Biorepository trial of children and adolescents/young adults (AYA)
    undergoing hematopoietic cell transplantation (HCT) to assess the impact of endotheliopathies in the HCT setting as a contributor of significant morbidity and mortality.

Primary Outcome Measure

Proportion of pediatric patients undergoing hematopoietic cell transplant (HCT) who develop endotheliopathies (SOS, TMA, DAH and IPS) and/or MODS within 100 days of such therapies. [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55902
Mira Kohorst
[email protected]
Duke UniversityDurhamNorth Carolina27705
Kris Mahadeo
[email protected]
919-668-1180
MD Anderson Cancer CenterHoustonTexas77030
Dristhi Ragoonanan
[email protected]

Find similar trials in Rochester, MN

By research site
Mayo Clinic· Rochester, MNDuke University· Durham, NCMD Anderson Cancer Center· Houston, TX

Related Studies