Prognostic Value of Confocal Endomicroscopy in Ulcerative Colitis: the CONF-UC Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 26
- 主要终点
- Prognostic Value of Confocal Endomicroscopy in Ulcerative Colitis
研究概览
简要总结
This study employs a prospective, single-center, interventional design to investigate the prognostic value of confocal endomicroscopy in assessing treatment response in ulcerative colitis (UC) patients receiving small molecules .
详细描述
The study incorporates confocal endomicroscopy as an additional diagnostic modality for assessing barrier dysfunction and treatment response in UC patients. Confocal endomicroscopy enables real-time visualization of mucosal changes at a cellular level during endoscopy, potentially enhancing the detection of treatment response and mucosal healing.
Eligible patients will undergo baseline assessment, including clinical evaluation, partial Mayo score calculation, endoscopic evaluation, biopsies with histological evaluation and confocal endomicroscopy. Follow-up assessments will be conducted at 8 weeks and 6 months after initiating therapy with small molecules .
The study aims to enroll a sample size of 26 UC patients to pilot the feasibility and utility of confocal endomicroscopy in assessing barrier dysfunction and treatment response.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established diagnosis of UC since at least 12 weeks prior to inclusion
- •Age ≥ 18 years
- •Any gender/sex
- •Active disease consistent with indication to start with Small molecules (defined as Mayo endoscopic score (MES) ≥ 1, partial Mayo score ≥ 3 (with at least rectal bleeding score of 1 and bowel movements score of 1)
- •No contraindications to endoscopy or confocal exam
- •Ability to understand and to comply with the study procedure and sign an informed consent form
排除标准
- •Subjects with an endoscopic Mayo sub-score at baseline <2;
- •Subjects with any contraindication to any study procedure (included fluorescein allergy).
结局指标
主要结局
Prognostic Value of Confocal Endomicroscopy in Ulcerative Colitis
时间窗: at 8 weeks and 6 months to treatment initiation
The study incorporates confocal endomicroscopy as an additional diagnostic modality for assessing barrier dysfunction and treatment response in UC patients. Confocal endomicroscopy enables real-time visualization of mucosal changes at a cellular level during endoscopy, potentially enhancing the detection of treatment response and mucosal healing.
次要结局
未报告次要终点
研究者
FEDERICA FURFARO
PhD, MD
IRCCS Ospedale San Raffaele