Predictive Efficacy of Fecal Calprotectin Assay by Magnetic Particle Chemiluminescence for Mucosal Healing in Moderate-to-Severe Ulcerative Colitis Patients Undergoing Initial Biologic Therapy: A Prospective, Multicenter, Observational Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 200
- 试验地点
- 10
- 主要终点
- Cut-off value and predictive efficacy of the early decline in fecal calprotectin for mucosal healing
研究概览
简要总结
This is a national prospective, multicenter, observational study. A total of 200 eligible patients will be enrolled from 10 hospitals across the country. Inclusion criteria are as follows: aged ≥ 18 years; diagnosed with moderate-to-severe active ulcerative colitis (UC); disease extent classified as E2 or E3; receiving biologic therapy for the first time; and having a confirmed UC diagnosis for more than 3 months. The follow-up period lasts 30-32 weeks. Six scheduled follow-up visits will be conducted at baseline, weeks 2-4, 6-8, 14-16, 22-24, and 30-32 after enrollment. The study endpoints are defined as: endoscopic mucosal healing (Mayo endoscopic score = 0 for UC), clinical judgment of inadequate response to current biologic therapy (i.e., continued treatment is unlikely to achieve mucosal healing and thus treatment switching or combined medication is required), or completion of the 30-32-week follow-up. The primary objective is to determine the cutoff value and predictive efficacy of the early (Weeks 2-4) reduction in fecal calprotectin (FC) measured by magnetic particle chemiluminescence assay for predicting mucosal healing in moderate-to-severe UC patients initiating biologic therapy.
详细描述
Ulcerative colitis (UC) is a chronic non-specific inflammatory bowel disease that mainly affects the rectum and colon. It is characterized by frequent relapse and protracted course. Its incidence has been rising rapidly, imposing a substantial economic burden on both patients and society. Biologic agents serve as key therapeutic options for UC and are widely used in the management of patients with moderate-to-severe disease. Mucosal healing (MH) is a core therapeutic goal for UC. Endoscopy is the primary modality to assess endoscopic MH, yet it is an invasive examination.
Fecal calprotectin (FC) is a specific biomarker for intestinal inflammation, which can accurately reflect the inflammatory status of the gut and acts as an ideal non-invasive biomarker for patients with UC. A large number of existing studies have demonstrated that FC is strongly correlated with clinical disease activity, endoscopic findings and histological parameters, highlighting its great value in disease assessment.
Magnetic particle chemiluminescence assay features high sensitivity, rapid detection, wide linear range, excellent precision and accuracy, as well as high degree of automation. It enables full-course monitoring of FC levels across mild, moderate and severe inflammatory stages as well as disease remission, providing evidence for evaluating therapeutic efficacy and optimizing treatment regimens. Hence, it is an optimal method for detecting FC concentrations.
This is a national prospective, multicenter, observational study. Eligible participants are patients aged 18 years or older with moderate-to-severe active UC, disease extent classified as Montreal E2 or E3, newly initiated biologic therapy, and a confirmed UC diagnosis of more than 3 months. The total follow-up duration is 30 to 32 weeks. During follow-up, stool samples are collected for FC measurement, along with clinical data and endoscopic results of the enrolled patients.
The study endpoints are defined as endoscopic mucosal healing, clinically confirmed inadequate response to the current biologic therapy (where continued treatment is unlikely to achieve mucosal healing, necessitating treatment switching or combined medication), or completion of the 30-32-week follow-up.
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
- •Aged ≥ 18 years;
- •Patients with ulcerative colitis receiving initial biologic therapy;
- •Confirmed diagnosis of ulcerative colitis for more than 3 months;
- •Moderate-to-severe disease activity;
- •Disease extent classified as E2 or E3;
- •Voluntarily signed the informed consent form and agreed to participate in this study.
排除标准
- •Aged under 18 years;
- •Patients who have previously received biologic therapy;
- •Patients with ulcerative colitis of disease extent E1;
- •Pregnant or lactating women;
- •Patients with contraindications to biologic agents;
- •Patients deemed unsuitable for this clinical study by clinical judgment.
结局指标
主要结局
Cut-off value and predictive efficacy of the early decline in fecal calprotectin for mucosal healing
时间窗: From enrollment to at the end of 30-32 weeks
Mucosal healing was defined as an endoscopic subscore of 0 according to the modified Mayo score system for assessing ulcerative colitis disease activity
次要结局
- Cutoff value and predictive performance of fecal calprotectin reduction for predicting sustained clinical response(From enrollment to at the end of 30-32 weeks follow-up)
- Cutoff value and predictive performance of fecal calprotectin reduction for predicting sustained endoscopic remission(From enrollment to at the end of 30-32 weeks follow-up)
- Dynamic correlation between fecal calprotectin levels and clinical disease activity(From enrollment to at the end of 30-32 weeks follow-up)
- Correlation between fecal calprotectin levels and endoscopic disease activity.(From enrollment to at the end of 30-32 weeks follow-up)