The Association Between Interleukin-7 Receptor Gene Polymorphism and the Risk of Ulcerative Colitis as Well as the Response to Vedolizumab
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 898
- 试验地点
- 1
- 主要终点
- Genotypes of IL-7R
研究概览
简要总结
From January 2020 to December 2024, diagnosed ulcerative colitis(UC) patients and gender- and age-matched normal controls were enrolled from the Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University. Investigators' aim is to investigate the associations of IL-7R gene polymorphisms with the risk and clinicopathological characteristics of UC, and to analyze the effects of IL-7R gene variations on the clinical response of vedolizumab(VDZ) treatment in UC patients.
详细描述
From January 2020 to December 2024, diagnosed UC patients and gender- and age-matched normal controls were enrolled from the Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University. Genotypes of IL-7R were determined by multiplex polymerase chain reaction-ligase detection reaction technique. Chi-square test and unconditional logistic regression model were used to analyze the difference in distribution of IL-7R gene polymorphisms between UC group and normal control group, as well as the effects of IL-7R gene variations on the clinicopathological characteristics and 14-week clinical response to VDZ treatment of participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diagnosed UC based on comprehensive clinical, colonoscopy, histopathological, laboratory, and radiographic examination results
排除标准
- •rheumatoid arthritis, systemic lupus erythematosus, intestinal tuberculosis, ischemic enteritis, radiation enteritis, tumors, etc.
研究组 & 干预措施
UC patients
Some UC patients received intravenous injection of VDZ (300mg/time) at weeks 0, 2, and 6, followed by intravenous injection of the same dose of VDZ every 8 weeks to maintain treatment.
干预措施: Vedolizumab (Biological)
normal control
no biological agents treatment
结局指标
主要结局
Genotypes of IL-7R
时间窗: Baseline
multiplex polymerase chain reaction-ligase detection reaction technique
次要结局
未报告次要终点