Iron buildup and liver problems in adults more than 10 years after an allogeneic stem cell transplant
Official title: Impact de la Surcharge en Fer Sur l'Incidence Des Complications hépatiques Chez Les Patients allogreffés de Cellules Souches hématopoïétiques à Plus de 10 Ans de la Greffe
Run by Assistance Publique - Hôpitaux de Paris · NCT07028112 · Data updated 2026-11-12
This project will see if long-term iron buildup raises the risk of liver complications in adults who had an allogeneic stem-cell transplant at least 10 years ago.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | August 20, 2025 |
| Main results expected | August 20, 2027 |
| Study ends | August 20, 2027 |
| Registry record updated | April 27, 2026 |
| Trial ID | NCT07028112 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older who had an allogeneic HSCT at Hôpital Saint Louis between January 1, 2004 and December 31, 2014, are alive and attending routine follow-up at the hospital at least 10 years after transplant, and have given non-opposition to participate.
✕Probably not a fit
Patients who were transplanted elsewhere, are less than 10 years post-transplant, have active relapse of their hematologic disease, are under legal protection, or weigh under 45 kg are not eligible and would not directly benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, non-interventional cohort of approximately 400–500 adults who received allogeneic HSCT at Hôpital Saint Louis between 2004 and 2014 and are at least 10 years post-transplant. Investigators will combine historical data from the Promise database (including transplant features, prior iron therapy, and past liver events) with prospective laboratory tests and non-invasive liver stiffness measurements by FibroScan or shear wave elastography. The primary aim is to see whether chronic iron overload influences the incidence of hepatic complications in long-term survivors. Secondary goals include describing the types and frequency of liver complications and identifying risk factors, including prior iron management and graft-related characteristics.
Why it matters
Potential benefit: If iron overload is linked to late liver disease, results could guide targeted monitoring and treatment to prevent or reduce liver complications in long-term transplant survivors.
How similar studies have gone: Previous observational reports link post-transplant iron overload to hepatic fibrosis and related complications and use elastography for noninvasive assessment, but large cohorts focused specifically on survivors beyond 10 years are limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Hôpital Saint Louis AP-HP
Paris, France Recruiting
Study contacts
- Study coordinator: Mathilde Ruggiu, MD
- Email: mathilde.ruggiu-goirand@aphp.fr
- Phone: 142494760
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.