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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AlloFer cohort | Adults transplanted at Hôpital Saint Louis (2004-2014) and alive ≥10 years post allo HSCT; evaluated once during routine annual follow up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cohort | Other | Participants undergo one routine visit blood draw and non invasive liver stiffness measurement. Retrospective data are abstracted from medical records. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Event free survival | From any hepatic complication ≥ 10 years after allogeneic HSCT | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall free survival of any hepatic complication ≥ 10 years after HSCT | Survival without hepatic complication | 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 |
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Inclusion Criteria:
Exclusion Criteria:
not in relapse of the hematological disease at the time of inclusion.
• Patients under 45 Kg
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mathilde Ruggiu, MD | Contact | 142494760 | +33 | mathilde.ruggiu-goirand@aphp.fr |
| Jérôme Lambert, MD PhD | Contact | 142499742 | +33 | jerome.lambert@u-paris.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Saint Louis AP-HP | Recruiting | Paris | France |
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Additional blood samples
| 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 | Up to 24 months |
| Event free survival from iron overload ≥ 10 years after HSCT | Time from HSCT to first diagnosis of iron overload | 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 | Up to 24 months |
| ID | Term |
|---|---|
| D019190 | Iron Overload |
| D006486 | Hemosiderosis |
| D008107 | Liver Diseases |
| D008103 | Liver Cirrhosis |
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D015331 | Cohort Studies |
| ID | Term |
|---|---|
| D016021 | Epidemiologic Studies |
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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