Construction and Validation of a Predictive Model for the Efficacy of Different Biologics in Inflammatory Bowel Disease
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: anti-cytokine antibodies, anti-integrin antibodies.
- Кому может быть актуально
- Состояния в реестре: Inflamatory Bowel Disease. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
Inflammatory bowel disease (IBD) is a group of chronic progressive gastrointestinal diseases that can recur throughout life and for which there is no cure. Biologics, the first line of treatment, are not only expensive, but also 30-50% of patients lack response to this type of drug therapy. However, there is a lack of reliable methods to predict the clinical efficacy of biologics. The aim of this study is to construct a reliable model to predict patients' response to biologics therapy by comprehensively analysing patients' clinical characteristics, biomarkers and other information to guide individualized therapy. In this study, we will collect clinical data from IBD patients at Peking University First Hospital, including but not limited to patients' baseline characteristics, biomarker levels, and efficacy responses, etc. We will establish a complete patient dataset using a cohort study, train and test the dataset by applying correlation analysis, multiple regression analysis, and machine learning algorithms (e.g. neural networks etc), establish and compare the prediction effects of different models The optimal model is selected for encapsulation and developed into a user-friendly clinical prediction tool. This study will contribute to clinical decision making for IBD patients, improve treatment outcomes, and reduce unnecessary healthcare costs.
Вмешательства
- Препарат anti-cytokine antibodies
Different kinds of biologics used to treat inflammatory bowel disease (including anti-cytokine antibodies) - Препарат anti-integrin antibodies
Different kinds of biologics used to treat inflammatory bowel disease (including anti-integrin antibodies)
Первичные конечные точки
- disease activity [Срок оценки: up to 8 weeks]
Критерии участия
Критерии включения
- Patients who are clinically diagnosed with IBD in our hospital
- Disease activity is in the active stage
- Receiving biologics after diagnosis
- Have relevant data on clinical evaluation results after receiving biologics treatment
Критерии исключения
- IBD patients who have not been treated with biologics after diagnosis
- Patients diagnosed with IBD but also with other autoimmune diseases that require biologics to be treated
- Patients with hematological diseases and other systemic chronic inflammatory diseases involving the intestine Patients with serious complications including malignant tumors and gastrointestinal perforation.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Китай · 1 центр
- Peking University First Hospital — Пекин
Идентификаторы
NCT: NCT07181525 · 2025R0267-0001