Идёт набор NCT06721767

Monitoring of Patients With Inflammatory Bowel Diseases: the Experience of the Reference Center of the Emilia-Romagna

— Наблюдательное IBD - 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: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: IBD - Inflammatory Bowel Disease. Базовые параметры: от 14 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: Италия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Multidisciplinary and Multiparametric Monitoring of Patients With Inflammatory Bowel Diseases: the Experience of the Reference Center of the Emilia-Romagna

Обзор

The study is observational with descriptive purposes, aimed at enhancing and deepening current knowledge and providing a foundation for future studies. Specifically, it seeks to identify predictive factors for aggressive disease progression, the development of frailty, the need for surgery and post-surgical outcomes, the development of neoplasia, the assessment of drug safety, and the quality of life in relation to medications or post-surgery.

Подробное описание

The total duration of the study is expected to be 10 years. Partial analyses will be conducted during the study for data publication. The clinical data required by the protocol will be collected in a pseudonymized form by personnel designated by the Principal Investigator in an electronic Case Report Form (CRF).

Analysis Methodology:

Descriptive statistical analyses will be used to describe the characteristics of the enrolled patient sample. Continuous variables will be summarized using means, standard deviations, minimum and maximum values, and percentiles. Discrete or nominal variables will be reported as absolute frequencies and relative percentage frequencies.

To study the predictive factors for disease progression, development of frailty, need for surgery, etc. (primary objectives), multivariate models (logistic regression analysis) will be used, and Odds Ratios with 95% confidence intervals (OR - CI 95%) will be calculated.

The calculation of frequencies and the estimation of event incidences, such as drug resistance, development of comorbidities, extraintestinal manifestations, and other observed episodes/events (secondary objectives) will be accompanied by their respective 95% confidence intervals (CI 95%). Analyses may focus on subcohorts of patients with different demographic and clinical-diagnostic characteristics to evaluate their varying risk probabilities.

Data will be processed using IBM SPSS statistical software (version 25.0).

Первичные конечные точки

Percentage of patients with aggressive disease progression. [Срок оценки: Baseline; through study completion, an average of 8 year]
Percentage of fragility patients. [Срок оценки: Baseline; through study completion, an average of 8 year]
Percentage of patients with the development of comorbidities. [Срок оценки: Baseline; through study completion, an average of 8 year]
Percentage of patients with extraintestinal manifestations (EIMs). [Срок оценки: Baseline; through study completion, an average of 8 year]
Percentage of patients who underwent surgery. [Срок оценки: Baseline; through study completion, an average of 8 year]
Percentage of patients with post-surgical complications. [Срок оценки: Baseline; through study completion, an average of 8 year]
Percentage of patients with a diagnosis of neoplastic disease. [Срок оценки: Baseline; through study completion, an average of 8 year]
Percentage of patients with drug resistance. [Срок оценки: Baseline; through study completion, an average of 8 year]

Вторичные конечные точки (5)

Percentage of patients with an adverse drug reaction. [Срок оценки: Baseline; through study completion, an average of 8 year]
IBD-Q score [Срок оценки: Baseline; through study completion, an average of 8 year]
Percentage of gastrointestinal and non-gastrointestinal infections. [Срок оценки: Baseline; through study completion, an average of 8 year]
Overall survival (OS) after the diagnosis of neoplastic/infectious disease. [Срок оценки: Baseline; through study completion, an average of 8 year]
Evaluation of the ergonomics of the tool and its data analysis performance. [Срок оценки: Baseline; through study completion, an average of 8 year]

Критерии участия

Критерии включения

Signed informed consent
Age > 14 years
Diagnosis of inflammatory bowel disease (Crohn's Disease, Ulcerative Colitis, Indeterminate Colitis, Microscopic Colitis) according to ECCO guidelines
Having undergone at least one outpatient visit and/or hospitalization at the Regional Reference Center for IBD "Massimo Campieri"
Acquisition of written informed consent from the patient and/or both parents/legal guardian