Impact of Iron Overload on the Incidence of Liver Complications in Long-Term Survivors (≥10 Years) of Allogeneic Hematopoietic Stem-Cell Transplantation.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cohort.
- Who it may be relevant to
- Registry conditions: Iron Overload, Hemosiderosis, Liver Diseases, Hematopoietic Stem Cell Transplantation (HSCT). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact de la Surcharge en Fer Sur l'Incidence Des Complications hépatiques Chez Les Patients allogreffés de Cellules Souches hématopoïétiques à Plus de 10 Ans de la Greffe
Overview
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.
Interventions
- Other Cohort
Participants undergo one routine visit blood draw and non invasive liver stiffness measurement. Retrospective data are abstracted from medical records.
Primary outcome measures
- Event free survival [Time frame: Up to 24 months]
Secondary outcome measures (5)
- Overall free survival of any hepatic complication ≥ 10 years after HSCT [Time frame: Up to 24 months]
- Event free survival from liver fibrosis ≥ 10 years after HSCT [Time frame: Up to 24 months]
- Event free survival for each specific hepatic complication ≥ 10 years after HSCT [Time frame: Up to 24 months]
- Event free survival from iron overload ≥ 10 years after HSCT [Time frame: Up to 24 months]
- Efficacy of curative treatments for iron overload in preventing hepatic complications [Time frame: Up to 24 months]
Eligibility criteria
Inclusion criteria
- 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
- With health insurance coverage
- Follow up consultation at Saint-Louis Hospital
Exclusion criteria
- Patient under legal protection (protection of the court, or in curatorship or guardianship).
not in relapse of the hematological disease at the time of inclusion.
- Patients under 45 Kg
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hôpital Saint Louis AP-HP — Paris
Identifiers
NCT: NCT07028112 · APH250402