High Dimensional Mass Cytometry as a Tool to Understand Ozanimod's Mechanism of Action (MOA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- difference in leukocyte subsets
研究概览
简要总结
The goal of this observational study is to learn about the mechanism of action of ozanimod in patients with ulcerative colitis (UC). The main questions it aims to answer are:
- Prospectively assess the effects of ozanimod on the cellular composition of intestinal lamina propria and blood by deep immunophenotyping (CyTOF) of immune cell subsets prior and after the drug's administration.
- Determine whether changes in cell subsets observed via mass cytometry correlate with with clinical or histologic parameters of disease activity.
Colonic biopsies and peripheral blood samples will be collected from patients with UC before and after the onset of ozanimod.
Researchers will compare intestinal and peripheral leukocytes before and after the drug's administration.
详细描述
Study Design/Methodology:
Several gastroenterologists at our center have agreed to assist with biopsy collection at our hospitals: UCSD: Singh, Boland, Patel, VA: Rivera-Nieves). Dr. Brian Behm who cares for most IBD patients at the University of Virginia has also agreed to assist with biopsy/PBMC collection.
During two visits (T0, T24-32) we will collect biopsies, endoscopies, histology, fecal and blood samples (Table 1), prospectively from a total of 10 UC patients scheduled for colonoscopy (before therapy with ozanimod and at 24-32 weeks post-treatment). A sample size of 10 patients per condition should be sufficient to achieve significant differences using CITRUS, based on required sample size determinations (see below).
The effects of the drug on cellular subsets will be assessed by comparing the two-time points (24-32 weeks post therapy) with its pretreatment control (T0). We will additionally compare the mass cytometry results to clinical parameters that are collected at our IBD center during every visit (Table 1). The clinical samples and parameters from patients recruited at UVA will be sent de-identified through a secure mailbox managed by the UVA.
Sample collection, storage, testing and analyses
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
- •Male or female patients aged 18 or older.
- •Have had UC diagnosed at least 3 months prior to screening. The diagnosis must be confirmed by endoscopic and histologic evidence.
- •Have active UC confirmed on endoscopy.
- •Ability to provide written informed consent to IBD biobank (UCSD)
- •Patients with above criteria being considered for ozanimod therapy and will not be treated in conjunction with biologics.
排除标准
- •Have severe IBD as evidenced by:physician judgment that the patient is likely to require colectomy or ileostomy within 12 weeks of baseline
- •Current evidence of fulminant colitis, toxic megacolon or bowel perforation
- •Previous total colectomy
- •Platelet count<100,000/μL
- •Have positive stool culture for pathogens (O+P, bacteria) or positive test for C. difficile at screening. If C. difficile is positive, the patient may be treated and retested.
- •Prisoners or subjects involuntarily detained will not be included.
结局指标
主要结局
difference in leukocyte subsets
时间窗: 3 years
difference in leukocyte subsets as determined by mass cytometry analyses
次要结局
未报告次要终点