Actively Recruiting
Impact of Iron Overload on Liver Complications in Adults 10+ Years After Allogeneic Hematopoietic Stem Cell Transplantation
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-04-27
500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether chronic iron overload affects the chances of liver problems in adults who are at least 10 years past receiving an allogeneic hematopoietic stem cell transplant (allo HSCT). The study will focus on about 400 to 500 survivors who had transplants at Hôpital Saint Louis between 2004 and 2014. It aims to understand the impact of iron overload on liver complications, describe the types and frequency of these complications, identify risk factors, and assess long-term effects of prior iron reduction treatments like phlebotomy or chelation. Participants will be evaluated once during their routine annual follow-up visit. The study involves collecting information from medical records about transplant details, previous treatments for iron overload, and past liver events. At the same time, blood tests and non-invasive liver stiffness measurements using FibroScan or shear wave elastography will be performed to assess liver health. During the study visit, researchers will gather lab results and perform liver assessments to monitor liver stiffness and related complications. They will track event-free survival and overall survival regarding liver issues for up to 24 months. The study will help clarify whether monitoring and treating iron overload in long-term allo HSCT survivors can help prevent late liver problems. Participation involves one visit, and all data will be collected during this time.
CONDITIONS
Brief Title
Impact of Iron Overload on the Incidence of Liver Complications in Long-Term Survivors (≥10 Years) of Allogeneic Hematopoietic Stem-Cell Transplantation.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older 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
- Provided non-opposition consent after understanding study aims
- Have health insurance coverage
- Follow-up consultation at Saint-Louis Hospital
You will not qualify if you...
- Patient under legal protection such as court guardianship or curatorship
- Patients currently in relapse of hematological disease at inclusion
- Patients weighing under 45 kilograms
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants who undergo routine care are observed. Measurements including blood draw and non-invasive liver stiffness are collected during routine annual follow-up visits.
1 visit during routine annual follow-up
Trial Site Locations
Total: 1 location
1
Hôpital Saint Louis AP-HP
Paris, France
Actively Recruiting
Research Team
M
Mathilde Ruggiu, MD
J
Jérôme Lambert, MD PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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