Iron buildup and liver problems in adults more than 10 years after an allogeneic stem cell transplant
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
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 |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT07028112 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Paris
- Hôpital Saint Louis AP-HP — Paris, France (Recruiting)
Study contacts
- Study coordinator: Mathilde Ruggiu, MD
- Email: mathilde.ruggiu-goirand@aphp.fr
- Phone: 142494760
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.