跳至主要内容
临床试验/NCT06813469
NCT06813469进行中(未招募)不适用

Multi-Dimensional Genomic Dissection of Ring Chromosome 14 Syndrome

IRCCS Azienda Ospedaliero-Universitaria di Bologna2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年12月15日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
15
试验地点
2
主要终点
LRS analysis of SVs occurring on chromosome 14

研究概览

简要总结

MD-RING will explore the hypothesis that position effects and TAD alterations act as an unprecedented pathomechanism in r(14)S. This will contribute to a better understanding of genotype-to-phenotype correlations, creating an important scientific resource for the study of this and other ring syndromes, with the ultimate objective to offer improved family counseling , patient care and to identify potential new therapeutic options.

详细描述

Chromosome 14 ring syndrome [r(14)S] is a rare genetic disorder mainly characterized by complex and severe neurodevelopmental disorders, ranging from intellectual disability to aggressive/hyperactive behavior and drug-resistant epilepsy. Indeed, epilepsy is the most important clinical challenge in r(14)S, with enormous difficulty in controlling severe seizures and a strong need for innovative and effective treatments. Precision medicine for r(14)S patients would be greatly facilitated by knowledge of specific genes involved in pathogenesis. However, the pathophysiology of r(14)S is still largely unknown, and the identification of genotype/phenotype correlations is complicated by the co-occurrence of chromosome 14 rearrangements and the unknown degree of r(14) mosaicism in tissues most relevant to the disease. On the one hand, deletions of different sizes, from a few hundred Kbs to several Mbs, are often found in the terminal 14q region. These are an unlikely explanation for the severity and expressiveness of r(14) disease, since it has been observed that carriers of similar linear deletions of chromosome 14q rarely suffer from epilepsy. On the other hand, ring instability may promote increased monosomy of chromosome 14 in epilepsy-related areas of the brain (it is about 20% in peripheral blood).

Another fascinating hypothesis is that the mechanism and expressiveness of r(14) disease are driven primarily by the disruption of chromosome 14 conformation and positioning within the nucleus caused by its circularization, with dramatic effects on physiological interactions between genetic loci and, consequently, on gene regulation . This idea revives an unresolved question in cytogenetic disorders, whether the chromosomal abnormality itself produces a clinical phenotype beyond the pathogenic effects of the altered gene dosage. Rings can form from any chromosome, and most ring syndromes share largely similar clinical phenotypes. Severe epilepsy, for example, has been described in r(7), r(17), r(18), r(20), r(21) and r(22) syndromes in addition to r(14)S . This observation suggests that the presence of a loop within the nucleus may itself disrupt the balance of gene expression.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
28 Days 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ten LCLs of r(14)S patients with 14q deletions of varying position and extent in 70%, and monosomy 14 of varying degree in 60%.
  • Five LCLs of parents without cytogenetic alterations.

排除标准

  • Ten LCLs of r(14)S patients with 14q deletions of varying position and extent in 70%, and monosomy 14 of varying degree in 60%.
  • Five LCLs of parents without cytogenetic alterations.

结局指标

主要结局

LRS analysis of SVs occurring on chromosome 14

时间窗: 8 months

1. Resolving the sequence breakpoints of structural ring rearrangement in patients with r(14)S. 2. Construct a 3D cell-specific molecular signature of r(14)S patients. 3. Identify regulatory mechanisms that are important in the pathophysiology of r(14)S.

次要结局

  • Genotype-phenotype correlations based on the impact of the degree of mosaicism r(14) on the ability to identify Hi-C features.(8 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Multi-Dimensional Genomic Dissection of Ring... | 临床试验