Status:
COMPLETED
Risk Factors and Measures to Prevent Liver and Pancreas Complications in Pediatric Patients After HSCT
Lead Sponsor:
University of Pisa
Collaborating Sponsors:
IRCCS Burlo Garofolo
University of Genova
Conditions:
Iron Overload
Eligibility:
All Genders
Up to 17 years
Brief Summary
Hematopoietic Stem Cell Transplantation (HSCT) is currently a standard procedure for a wide range of blood-oncological diseases and genetic disorders. Recent improvements in transplant technologies, i...
Detailed Description
The present retrospective study will be conducted at the Bone Marrow Transplant Center, IRCCS Burlo Garofolo, Trieste, Italy. All pediatric patients who underwent one or more allogeneic HSCTs between ...
Eligibility Criteria
Inclusion
- one or more allogeneic HSCT
- any type of disease (blood-oncological or genetic), from any type of donor (sibling, MUD, haploidentical) and with any source of stem cells (spinal cord, peripheral blood stem cells, cord blood)
- diagnosis of moderate-to-severe siderosis (by nuclear magnetic resonance imaging, MRI) and who needed a chelation treatment with deferasirox
- one or more liver biopsies in the post-transplant period to perform histological examinations
- Complete results from lab analyses
- 2-year follow-up after HSCT
- therapeutic drug monitoring (TDM) protocol for deferasirox plasma concentration as per clinical routine
- Sign of the informed consent by the parents or legal representatives
Exclusion
- Lack of liver biopsies after transplantation, results from laboratory analyses or TDM or MRI
- Lack of informed consent
Key Trial Info
Start Date :
September 30 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT04423237
Start Date
September 30 2020
End Date
December 31 2024
Last Update
June 3 2025
Active Locations (1)
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1
IRCCS Burlo Garofolo
Trieste, Italy, 34137