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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patient under legal protection (protection of the court, or in curatorship or guardianship).

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Cohort

    Other intervention

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

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: AlloFer cohort1 intervention

Trial outcomes

Primary outcomes

1

Event free survival

From any hepatic complication ≥ 10 years after allogeneic HSCT

Time frame
Up to 24 months

Secondary outcomes

1

Overall free survival of any hepatic complication ≥ 10 years after HSCT

Survival without hepatic complication

Time frame
Up to 24 months
2

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

Time frame
Up to 24 months
3

Event free survival for each specific hepatic complication ≥ 10 years after HSCT

Separate analyses for cirrhosis, portal hypertension, hepatic GVHD, viral hepatitis, steatosis, etc

Time frame
Up to 24 months
4

Event free survival from iron overload ≥ 10 years after HSCT

Time from HSCT to first diagnosis of iron overload

Time frame
Up to 24 months

Other outcomes

Sponsors and contacts

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