RecruitingNot Applicable

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

United States500 participantsStarted 2019-11-19

Plain-language 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.

Who can participate

Age range0 Years – 26 Years

SexALL

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: * 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.

What they're measuring

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.

Timeframe: 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.

Timeframe: 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.

Timeframe: 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.

Timeframe: through study completion, an average of 1 year

Trial details

NCT IDNCT05090345

SponsorDuke University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-02-05

Contact for this trial

LaTarsha Spencer

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

View on ClinicalTrials.gov More Hematopoietic Cell Transplantation trials

Who can participate

Age range0 Years – 26 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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.

Timeframe: 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.

Timeframe: 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.

Timeframe: 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.

Timeframe: through study completion, an average of 1 year