Clinical trial NCT06721767: Monitoring of Patients With Inflammatory Bowel Diseases: the Experience of the Reference Center of the Emilia-Romagna
Official title: The Multidisciplinary and Multiparametric Monitoring of Patients With Inflammatory Bowel Diseases: the Experience of the Reference Center of the Emilia-Romagna
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: IBD - Inflammatory Bowel Disease
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 10000
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population consists of adult patients with IBD being followed at the Regional Reference Center "Massimo Campieri," which includes the General Surgery Unit and the IBD Specialties Unit of IRCCS AOUBO for the management of intestinal and extraintestinal conditions. Enrollment will take place in the IBD Specialties Unit during follow-up outpatient visits, hospital admissions, or through a phone/email invitation conducted by staff affiliated with the Unit.

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

- None

Primary outcomes:
measure: Percentage of patients with aggressive disease progression.
timeFrame: Baseline; through study completion, an average of 8 year
measure: Percentage of fragility patients.
timeFrame: Baseline; through study completion, an average of 8 year
measure: Percentage of patients with the development of comorbidities.
timeFrame: Baseline; through study completion, an average of 8 year
measure: Percentage of patients with extraintestinal manifestations (EIMs).
timeFrame: Baseline; through study completion, an average of 8 year
measure: Percentage of patients who underwent surgery.
timeFrame: Baseline; through study completion, an average of 8 year
measure: Percentage of patients with post-surgical complications.
timeFrame: Baseline; through study completion, an average of 8 year
measure: Percentage of patients with a diagnosis of neoplastic disease.
timeFrame: Baseline; through study completion, an average of 8 year
measure: Percentage of patients with drug resistance.
timeFrame: Baseline; through study completion, an average of 8 year
Secondary outcomes:
measure: Percentage of patients with an adverse drug reaction.
timeFrame: Baseline; through study completion, an average of 8 year
measure: IBD-Q score
timeFrame: Baseline; through study completion, an average of 8 year
measure: Percentage of gastrointestinal and non-gastrointestinal infections.
timeFrame: Baseline; through study completion, an average of 8 year
measure: Overall survival (OS) after the diagnosis of neoplastic/infectious disease.
timeFrame: Baseline; through study completion, an average of 8 year
measure: Evaluation of the ergonomics of the tool and its data analysis performance.
timeFrame: Baseline; through study completion, an average of 8 year
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Fernando Rizzello, MD
role: PRINCIPAL_INVESTIGATOR
References: