An observational study in Iron Overload, Hemosiderosis and Liver Diseases, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-27.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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.
14 studies on the registry are indexed under Hemosiderosis; 1 is open to participants now.
Browse Hemosiderosis studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
Compared within Hemosiderosis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Iron Overload. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
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Exclusion Criteria:
not in relapse of the hematological disease at the time of inclusion.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults transplanted at Hôpital Saint Louis (2004-2014) and alive ≥10 years post allo HSCT; evaluated once during routine annual follow up
Other: Cohort
Participants undergo one routine visit blood draw and non invasive liver stiffness measurement. Retrospective data are abstracted from medical records.
Event free survival
From any hepatic complication ≥ 10 years after allogeneic HSCT
Time frame: Up to 24 months
Overall free survival of any hepatic complication ≥ 10 years after HSCT
Survival without hepatic complication
Time frame: Up to 24 months
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
Time frame: Up to 24 months
Event free survival for each specific hepatic complication ≥ 10 years after HSCT
Separate analyses for cirrhosis, portal hypertension, hepatic GVHD, viral hepatitis, steatosis, etc
Time frame: Up to 24 months
Event free survival from iron overload ≥ 10 years after HSCT
Time from HSCT to first diagnosis of iron overload
Time frame: Up to 24 months
Efficacy of curative treatments for iron overload in preventing hepatic complications
International non-proprietary names, dates and doses of treatments received for iron overload ≥ 10 years after HSCT
Time frame: Up to 24 months
Plan to share: Undecided
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