About this trial
This single-center, non interventional cohort study investigates whether chronic iron overload influences the incidence of liver complications in adults who are at least 10 years beyond allogeneic hematopoietic stem cell transplantation (allo HSCT). Approximately 400-500 survivors transplanted at Hôpital Saint Louis between January 2004 and December 2014 will be evaluated. Transplant characteristics, prior iron overload therapy, and historical hepatic events will be collected through the Promise database. At the same time, the prospective visit will include laboratory panels and non invasive liver stiffness measurement by FibroScan or shear wave elastography. The study's primary objective is to assess the impact of iron overload on the incidence of hepatic complications in patients more than 10 years after an allogeneic hematopoietic stem cell transplantation. Secondary aims include describing the spectrum and frequency of hepatic complications, determining risk factors (including graft versus host disease, conditioning regimen, and comorbidities), and evaluating the long term effectiveness of previous iron reduction treatments (phlebotomy or chelation). Results will clarify whether monitoring and treating iron overload in long term allo HSCT survivors can prevent late hepatic morbidity.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years at enrollment
Allogeneic HSCT performed at Hôpital Saint Louis between 2004/01/01 and 2014/12/31
Alive and attending routine annual follow up within the two years of the study
Having given his non-opposition to study after understand overall aims
Disqualifiers
Patient under legal protection (protection of the court, or in curatorship or guardianship).
Trial population
Adults (\>18 years) who received allo HSCT at Hôpital Saint Louis (2004/01/01 and 2014/12/31) and are alive and attending annual follow up ≥10 years post transplant.
Trial design
Cohort
Prospective
Treatments tested in this trial
Cohort
Other interventionParticipants undergo one routine visit blood draw and non invasive liver stiffness measurement. Retrospective data are abstracted from medical records.
Treatment groups
Trial outcomes
Primary outcomes
Event free survival
From any hepatic complication ≥ 10 years after allogeneic HSCT
Secondary outcomes
Overall free survival of any hepatic complication ≥ 10 years after HSCT
Survival without hepatic complication
Event free survival from liver fibrosis ≥ 10 years after HSCT
Time from HSCT to first diagnosis of liver fibrosis by elastography (FibroScan® ≥ 8 kPa or shear wave ≥ 7 kPa). baseline to fibrosis diagnosis
Event free survival for each specific hepatic complication ≥ 10 years after HSCT
Separate analyses for cirrhosis, portal hypertension, hepatic GVHD, viral hepatitis, steatosis, etc
Event free survival from iron overload ≥ 10 years after HSCT
Time from HSCT to first diagnosis of iron overload
Sponsors and contacts
Click on the lead sponsor to view all of their trials.