NCT07358923尚未招募不适用
Accuracy of Modified Milan Ultrasound Criteria in Assessing Disease Activity and Severity in Moderate-to-Severe Ulcerative Colitis: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
研究概览
简要总结
Longitudinal prospective monocentric observational study in which patients to start Mirikizumab for normal clinical practice will be followed for 24 weeks. Based on the findings in the comparison between US (IUS and TPUS) and endoscopy, the study aim is to build up a modified MUC (Milan Ultrasound Criteria) scoring system taking each colonic segment and the rectum into account, developing non-invasive quantitative ultrasound-based criteria to identify patients with active UC and assess its severity.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Age ≥ 18 years
- •Confirmed diagnosis of UC according to ECCO guidelines
- •Patients with active moderate-to-severe disease defined as MES
- •Patients undergoing advanced therapies with mirikizumab according to clinical judgement
- •Patients who provide written informed consent
排除标准
- •Age < 18 years
- •Patients with unclassified colitis or other gastrointestinal conditions
- •Patients with current infections or other severe comorbidity, including liver, kidney or cardiac failure, which contraindicate the initiation of advanced therapy
- •Patients unable or unwilling to provide consent
研究者
Mariangela Allocca
MD, PhD
IRCCS San Raffaele
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