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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Event free survival
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
AlloFer cohort
Adults transplanted at Hôpital Saint Louis (2004-2014) and alive ≥10 years post allo HSCT; evaluated once during routine annual follow up
干预措施: Cohort (Other)
结局指标
主要结局
Event free survival
时间窗: Up to 24 months
From any hepatic complication ≥ 10 years after allogeneic HSCT
次要结局
- 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)
