Recruiting

Observational Study

Sponsor:

Duke University

Code:

NCT05090345

Conditions

Hematopoietic Cell Transplantation

Eligibility Criteria

Sex: All

Age: 0 - 26

Healthy Volunteers: Not accepted

Interventions

Biorepository Trial

Study Details

Brief summary:

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.

Conditions

Hematopoietic Cell Transplantation

Study ID

NCT05090345

Start date

Nov 19, 2019

Status verified date

May, 2026

Completion date

Feb 5, 2028

Anticipated

Primary completion date

Feb 5, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 26

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Children, adolescents and young adults (AYA) 0-26 years of age undergoing HSCT.
  • Recipients of autologous and allogeneic HSCT.
  • Any preparative regimen.

Exclusion Criteria:

  • Any patient who does not consent/assent to participation.
  • Any patient for whom 5 mL blood sample(s) drawn at specified intervals would pose any more than minimal risk, as defined by institutional guidelines and at discretion of treating physician will be ineligible for biorepository banking.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Biorepository Trial

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

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 ]
  • Proportion of pediatric patients undergoing (HCT) who experience abnormal levels of circulating angiogenic factors within 100 days post HCT-CT in the setting of endotheliopathies. [ Time Frame: through study completion, an average of 1 year ]
  • Proportion of pediatric patients undergoing (HCT) who experience abnormal levels of vascular permeability within 100 days post HCT-CT in the setting of endotheliopathies. [ Time Frame: through study completion, an average of 1 year ]
  • Proportion of pediatric patients undergoing (HCT) who experience abnormal levels of inflammatory factors within 100 days post HCT-CT in the setting of endotheliopathies. [ Time Frame: through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

LaTarsha Spencer

(919) 613-1895latarsha.spencer@duke.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55902

Contacts

Mira Kohorst

kohorst.mira@mayo.edu

Duke University

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Kris Mahadeo

919-668-1180kris.mahadeo@duke.edu

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Dristhi Ragoonanan

DRagoonanan@mdanderson.org

More Information

Sponsor

Duke University

Last update posted

Jun 1, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-06-01.