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

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2027-07-01

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.

Conditions

Iron Overload; Hemosiderosis; Liver Diseases; Hematopoietic Stem Cell Transplantation (HSCT)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

AlloFer cohort

Adults transplanted at Hôpital Saint Louis (2004-2014) and alive ≥10 years post allo HSCT; evaluated once during routine annual follow up

Cohort

Intervention Type: OTHER

Participants undergo one routine visit blood draw and non invasive liver stiffness measurement. Retrospective data are abstracted from medical records.

Interventions

Cohort

Participants undergo one routine visit blood draw and non invasive liver stiffness measurement. Retrospective data are abstracted from medical records.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Mathilde Ruggiu, MD

Role: CONTACT

mathilde.ruggiu-goirand@aphp.fr

142494760 ext. +33

Jérôme Lambert, MD PhD

Role: CONTACT

jerome.lambert@u-paris.fr

142499742 ext. +33

Other Identifiers

APH250402

Identifier Type: -

Identifier Source: org_study_id