NCT07028112 Impact of Iron Overload on the Incidence of Liver Complications in Long-Term Survivors (≥10 Years) of Allogeneic Hematopoietic Stem-Cell Transplantation.
| NCT ID | NCT07028112 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Iron Overload |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-08-20 |
| Primary Completion | 2027-08-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2025-08-20 with a primary completion date of 2027-08-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07028112 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Iron Overload. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07028112 currently recruiting?
Yes, NCT07028112 is actively recruiting participants. Contact the research team at mathilde.ruggiu-goirand@aphp.fr for enrollment information.
Where is the NCT07028112 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT07028112 clinical trial?
NCT07028112 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 500 participants.