RECRUITING

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

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

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.

Official Title

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

Quick Facts

Study Start:2019-11-19
Study Completion:2026-02-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05090345

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:0 Years to 26 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Children, adolescents and young adults (AYA) 0-26 years of age undergoing HSCT.
  2. * Recipients of autologous and allogeneic HSCT.
  3. * Any preparative regimen.
  1. * Any patient who does not consent/assent to participation.
  2. * 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.

Contacts and Locations

Study Contact

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

Principal Investigator

Kris Mahadeo
PRINCIPAL_INVESTIGATOR
Duke University

Study Locations (Sites)

Mayo Clinic
Rochester, Minnesota, 55902
United States
Duke University
Durham, North Carolina, 27705
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Duke University

  • Kris Mahadeo, PRINCIPAL_INVESTIGATOR, Duke University

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 Date2019-11-19
Study Completion Date2026-02-05

Study Record Updates

Study Start Date2019-11-19
Study Completion Date2026-02-05

Terms related to this study

Additional Relevant MeSH Terms

  • Hematopoietic Cell Transplantation