NCT06604273招募中2 期
Unravelling Intestinal Fibrosis in Ulcerative Colitis
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年4月3日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Candidate fibrotic cellular pathways
研究概览
简要总结
The main objectives are: (i) to identify candidate fibrotic cellular pathways in UC patients treated with a JAK inhibitor filgotinib), and (ii) to detect and monitor in vivo fibrosis in UC patients using FAPi-PET/CT imaging
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- •Adults with confirmed diagnosis of UC - Group 1 criterion: ≥18 years of age regardless of gender
- •Group 2 criterion: ≥30 years of age for males and ≥40 years of age for females
- •Active disease confirmed by endoscopy (endoscopic Mayo score ≥ 2)
- •Indication to start treatment with filgotinib
- •AND one of the following criteria:
- •Active disease confirmed by intestinal ultrasound (BWT > 3 mm in at least one bowel segment and at least one other pathological IUS parameter) or
- •Increased CRP (>5 mg/L) and/or fecal calprotectin levels (>250 mg/kg)
排除标准
- •Pregnancy
- •Unable to provide informed consent
- •Colorectal carcinoma or high-grade dysplasia
结局指标
主要结局
Candidate fibrotic cellular pathways
时间窗: From enrollment to end of study participation at 24 weeks
Identification of candidate fibrotic cellular pathways using single cell pathway analysis and mucosal biopsies from UC patients before and at week 24 weeks after treatment initiation with filgotinib.
次要结局
- 68Ga-FAPi-PET/CT imaging feasibility(From enrollment to end of study participation at 24 weeks)
- Correspondance 68Ga-FAPi uptake and STAT expression(From enrollment to end of study participation at 24 weeks)
- Correspondance 68Ga-FAPi uptake and clinical and endoscopic parameters(From enrollment to end of study participation at 24 weeks)
研究者
Dalia Lartey
Drs
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
研究点 (2)
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