跳至主要内容
临床试验/NCT07459816
NCT07459816招募中不适用

Genomic of CONgenital Sideroblastic Anemias

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年10月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Identification of genetic variants in Congenital sideroblastic anemias

研究概览

简要总结

Congenital sideroblastic anemias (CSA) are a group of rare disorders characterized by abnormal iron utilization during erythropoiesis, leading to mitochondrial iron overload, the formation of ring sideroblasts, and ineffective erythropoiesis resulting in anemia. Ring sideroblasts are erythroid precursors that contain non-heme iron deposits in their mitochondria, forming a distinctive ring-like pattern around the nucleus. Mitochondria are double membrane organelle provide a large amount of energy for cellular activities, by the process of oxidative phosphorylation (OXPHOS). The role of mitochondria has been well described in erythropoiesis. CSA exhibits clinical heterogeneity, affecting only the erythroid system in some cases, while in others presenting as part of broader syndromic conditions. Their molecular basis remains imperfectly known, although the development of next- generation sequencing technology brought tremendous advances in the understanding of their genetic features. More than 20 genes have been identified as causative of CSA, with all modes of inheritance observed: X-linked recessive, autosomal dominant, autosomal recessive, pseudo- dominant, and mitochondrial. These genes are typically involved in one of four key mitochondrial pathways: i) Heme biosynthesis (e.g., ALAS2, SLC25A38); ii) Iron-sulfur cluster biosynthesis and transport (e.g., GLRX5, HSPA9, HSCB); iii) tRNA synthesis and maturation (e.g., PUS1, YARS2, LARS2, IARS2, SARS2, MARS1, TRNT1); iv) Mitochondrial respiratory chain synthesis (e.g., NDUFB11).

However, in nearly 30% of cases within the French CSA cohort, the underlying genetic cause remains unknown. In these patients with molecularly unexplained whole genome or exome sequencing approaches focusing on genes involved in mitochondrial function and iron metabolism identified several possibly pathogenic variants in CSA patients. These genes were not clearly described as playing a role in erythropoiesis or heme or iron metabolism. We hope to confirm their role in CSA. However, in nearly 30% of cases within the French CSA cohort , the underlying genetic cause remains unknown. The investigators hope to confirm the role in CSA of gene identified with exome sequencing approaches.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patient with unexplained congenital sideroblastic anemia on the molecular side with the gene panels used routinely
  • Patients already identified by exome sequencing approach carrying bi-allelic variants of candidate genes of the mitochondrial respiratory pathway.
  • Patients meeting the same criteria who will be identified prospectively over the next 12 months

排除标准

  • 未提供

研究组 & 干预措施

Congenital sideroblastic anemia

Experimental

干预措施: blood redrawal (Biological)

Patients without Congenital sideroblastic anemia

Active Comparator

干预措施: blood redrawal (Biological)

结局指标

主要结局

Identification of genetic variants in Congenital sideroblastic anemias

时间窗: 1 year

Variants potentially altering the splicing site

Identification of nonsense and missense genetic variants in Congenital sideroblastic anemias

时间窗: 1 year

Nonsense and missense variants: study of protein expression or protein size by Western Blot or protein-protein interactions in blood mononuclear cells

次要结局

  • level of mitochondrial membrane potential(1 year)
  • Measurement of mitochondrial Ros production(1 year)
  • Measurement of mitochondrial mass(1 year)
  • Measurement of erythroid differentiation(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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