Predictive Efficacy of Fecal Calprotectin Assay by Magnetic Particle Chemiluminescence for Mucosal Healing in Moderate-to-Severe Ulcerative Colitis Patients Undergoing Initial Biologic Therapy（PRECAL） (PRECAL)
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
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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.
The primary objective is to determine the cutoff value and predictive performance of the early (Weeks 2-4) reduction in FC measured by magnetic particle chemiluminescence assay for predicting mucosal healing in moderate-to-severe UC patients receiving initial biologic therapy.
The secondary objectives are as follows:
- To identify the cutoff value and predictive performance of the early (Weeks 2-4) FC reduction detected via magnetic particle chemiluminescence assay for predicting sustained clinical response in moderate-to-severe UC patients on initial biologic therapy;
- To explore the cutoff value and predictive performance of the early (Weeks 2-4) FC reduction for predicting sustained endoscopic remission in the above patient population;
- To analyze the dynamic correlation between FC levels measured by magnetic particle chemiluminescence assay and clinical disease activity;
- To assess the correlation between FC levels and endoscopic disease activity;
- To establish a predictive model for mucosal healing at Weeks 30-32 in UC patients by combining symptom scores, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), FC levels and their reduction ranges.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Места учебы
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Dalian, Китай, 116023
- The Second Hospital of Dalian Medical University
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Beijing Municipality
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Beijing, Beijing Municipality, Китай, 100044
- Peking University People's Hospital
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Китай, 401121
- Chongqing General Hospital
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Guangdong
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Shenzhen, Guangdong, Китай, 518101
- Shenzhen Hospital, Southern Medical University
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Hubei
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Wuhan, Hubei, Китай, 430022
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Jiangsu
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Nanjing, Jiangsu, Китай, 210009
- Zhongda Hospital, Southeast University
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Liaoning
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Shengyang, Liaoning, Китай, 110004
- Shengjing Hospital of China Medical University,
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Shandong
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Qingdao, Shandong, Китай, 266035
- Qilu Hospital (Qingdao), Shandong University
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Shanxi
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Xi’an, Shanxi, Китай, 710038
- Tangdu Hospital, Air Force Medical University
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Xi’an, Shanxi, Китай, 710077
- The First Affiliated Hospital of Xi'an Medical University
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
moderate-to-severe UC patients
Patients with ulcerative colitis who are aged ≥ 18 years, have moderate-to-severe disease activity, present with disease extent E2 or E3, receive biologic therapy for the first time, and have a confirmed diagnosis of ulcerative colitis for more than 3 months
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Fecal calprotectin detection by magnetic particle chemiluminescence assay
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Cut-off value and predictive efficacy of the early decline in fecal calprotectin for mucosal healing
Временное ограничение: From enrollment to at the end of 30-32 weeks
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Mucosal healing was defined as an endoscopic subscore of 0 according to the modified Mayo score system for assessing ulcerative colitis disease activity
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From enrollment to at the end of 30-32 weeks
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Cutoff value and predictive performance of fecal calprotectin reduction for predicting sustained clinical response
Временное ограничение: From enrollment to at the end of 30-32 weeks follow-up
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clinical symptom remission is defined as a score of 0 for both Stool Frequency (SF) and Rectal Bleeding(RB) in the Mayo score; or a score of 0 for RB, plus an SF score of ≤1 with a reduction of at least 1 point from baseline
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From enrollment to at the end of 30-32 weeks follow-up
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Cutoff value and predictive performance of fecal calprotectin reduction for predicting sustained endoscopic remission
Временное ограничение: From enrollment to at the end of 30-32 weeks follow-up
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Endoscopic remission is defined as an endoscopic subscore of 0 or 1 in the Mayo score (excluding the finding of mucosal friability)
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From enrollment to at the end of 30-32 weeks follow-up
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Dynamic correlation between fecal calprotectin levels and clinical disease activity
Временное ограничение: From enrollment to at the end of 30-32 weeks follow-up
|
Fecal calprotectin and Mayo score data will be collected at each follow-up time point to analyze their dynamic correlation
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From enrollment to at the end of 30-32 weeks follow-up
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Correlation between fecal calprotectin levels and endoscopic disease activity.
Временное ограничение: From enrollment to at the end of 30-32 weeks follow-up
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Fecal calprotectin and Mayo endoscopic subscore data will be collected at each follow-up time point to assess their correlation.
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From enrollment to at the end of 30-32 weeks follow-up
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Predictive model for mucosal healing at Weeks 30-32 in UC patients by combining symptom scores, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), fecal calprotectin levels and their decreasing ranges
Временное ограничение: From enrollment to at the end of 30-32 weeks follow-up
|
Multivariate regression analysis will be performed using patients' demographic data, disease characteristics, medication information, Mayo scores, ESR, CRP and fecal calprotectin levels, so as to develop a predictive model for mucosal healing at Weeks 30-32 among moderate-to-severe ulcerative colitis patients treated with biologic agents.
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From enrollment to at the end of 30-32 weeks follow-up
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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- FCTSTUDY001
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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