Impact of Iron Overload on the Incidence of Liver Complications in Long-Term Survivors (≥10 Years) of Allogeneic Hematopoietic Stem-Cell Transplantation. (AlloFer)

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

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

Treatments: Other: Cohort

Study type: Observational

Funder types: Other

Identifiers

NCT07028112

APH250402

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

AlloFer cohort

Description:

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

Treatment:

Other: Cohort