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

NCT07028112 | Recruiting

• 1 other identifier: APH250402
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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)

Keywords

Iron overload; Liver fibrosis; Elastography; Long-term complications; Allogeneic hematopoietic stem-cell transplantation; graft-versus-host disease

Outcome Measures

Primary Outcomes (1)

• Event free survival

  From any hepatic complication ≥ 10 years after allogeneic HSCT

  Up to 24 months

Secondary Outcomes (5)

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

  Up to 24 months

• Event free survival from liver fibrosis ≥ 10 years after HSCT

  Up to 24 months

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

  Up to 24 months

• Event free survival from iron overload ≥ 10 years after HSCT

  Up to 24 months

• Efficacy of curative treatments for iron overload in preventing hepatic complications

  Up to 24 months

Study Arms (1)

AlloFer cohort

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

Other: Cohort

Interventions

Cohort OTHER

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

AlloFer cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• Patient under legal protection (protection of the court, or in curatorship or guardianship).
• Patients under 45 Kg

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Saint Louis AP-HP

Paris, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Additional blood samples

MeSH Terms

Conditions

Iron Overload; Hemosiderosis; Liver Diseases; Liver Cirrhosis; Graft vs Host Disease

Interventions

Cohort Studies

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Mathilde Ruggiu, MD

CONTACT

142494760; mathilde.ruggiu-goirand@aphp.fr

Jérôme Lambert, MD PhD

CONTACT

142499742; jerome.lambert@u-paris.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 19, 2025
• Study Start: August 20, 2025
• Primary Completion (Estimated): August 20, 2027
• Study Completion (Estimated): August 20, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

FR (1)