Study to Evaluate the Epidemiology and the Characteristics "Omics" in Patients Recently Diagnosed of Inflammatory Bowel Disease in Spain (IBDomics)

July 28, 2020 updated by: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Prospective and Multicenter Study About the Epidemiology and the Characteristics "Omics" in Patients Recently Diagnosed of Inflammatory Bowel Disease in Spain

This is a prospective, observational, multicenter, population-based incidence cohort study which will enroll cases of inflammatory bowel disease IBD (Crohn´s disease CD, ulcerative colitis UC, or indeterminate colitis) diagnosed in adults over 18 months in Spain.

In addition, each incident case that gave his/her informed consent, will be followed up for 12 months to determine changes in phenotype or disease location, the need for immunosuppressive and biologic treatments, and the need for hospital admissions and surgery during the first year after diagnosis.

Also, samples of of blood, urine and stool will be collected during the first year after diagnosis

Study Overview

Status

Completed

Conditions

Detailed Description

STUDY DESIGN This is a prospective, observational, multicenter, population-based incidence cohort study which will enroll cases of IBD (CD, UC, or indeterminate colitis) diagnosed in adults over 18 months in Spain.

In addition, each incident case that gave his/her informed consent, will be followed up for 12 months to determine changes in phenotype or disease location, the need for immunosuppressive and biologic treatments, and the need for hospital admissions and surgery during the first year after diagnosis.

Samples of blood, urine and stool will be collected during the study visits.

To achieve the aims this study will be Split in two studies.

  1. Epidemiology study to achieve aims 1 and 2.
  2. Characterization "omics" study to achieve aims 3, 4 and 5.

CASES DETECION

Case detection In Spain, health care is performed mostly by the public health services. According to recent data, approximately 15% of the Spanish population has private health insurance (Informe Sanidad Privada: Aportando Valor. Análisis de situación 2014 (Report on Private Health Care: Providing Value. 2014 Situation Analysis); available at: https://www.fundacionidis.com/wp-content/informes/informe_analisis situac_2014_0.pdf). In addition, of those persons having private health insurance, only about 15% make exclusive use of it. For these reasons and taking into account the specific characteristics of IBD, the risk of underestimating the incidence of IBD considering only cases seen in public health centers would be of little relevance. Therefore, this study will be conducted at centers providing public health care within the National Health System.

To conduct this research project, an IBD specialist who is a member of GETECCU has been selected from each Autonomous Community, who will include patients from their health area.

Each participating investigator will confirm the diagnosis at the time of entering patients in the study and 3 months later to assure this diagnosis and the phenotypic characteristics of the disease, and thereby have greater diagnostic accuracy. External monitoring of incident cases included in the registry will also be performed by review of cases selected at random by the research team of Hospital Universitario de la Princesa.

DEFINITIONS

  • Disease location and phenotype: IBD location and phenotype will be defined according to the Montreal classification.
  • Time to diagnosis: It will be defined as the time from the first medical consultation made by the patient after onset of symptoms to the diagnosis of IBD.
  • Population center: The type of population center at the patient's birth and at diagnosis of IBD will be recorded. Whether the population center of origin of the patient is considered rural or urban will be based on the classification of the National Statistics Institute (INE) of each municipality.
  • Socioeconomic level: Socioeconomic level will be assessed through different variables, such as the patient's educational level (primary education or lower, secondary education, higher education or equivalent), occupational status (self-employed, employee, unemployed, retired), professional status (nonsalaried or salaried) and type of working hours (full time or part time).
  • Number of cohabitants: The number of cohabitants in the patient's home during childhood (up to 16 years) and at diagnosis of IBD will be recorded.
  • Smoking: Smoking status will be categorized as "nonsmoker", "smoker", or "ex-smoker", and will be considered at the time of diagnosis of IBD. Patients will be considered "smokers" if they have a smoked more than 7 cigarettes per week for at least 6 months or smoked at least 1 cigarette in the 6 months prior to diagnosis. Patients will be considered "ex-smokers" l if they quit smoking at least 6 months before diagnosis. Patients will be considered "nonsmokers" if they never smoked or did so in a very small amount or occasionally.
  • Treatments: Treatments received by the patient in the 12 months since diagnosis of the disease will be included, provided they were received for IBD. Only the first prescription of each therapeutic group will be recorded.
  • Changes in phenotype: Changes in phenotype will be considered as the appearance of new lesions not present at diagnosis subsequent to the initial tests performed to determine disease extent and severity. In these cases, the phenotype, the complication leading to classification of the patient in a different phenotype and date of occurrence of the complication will be recorded.
  • Hospital admission Hospital admission occurring during the first year from diagnosis of the disease will be included. The date of admission, date of discharge, if related or not to IBD and the cause of admission.
  • Surgical procedures: The surgical procedures performed on the patient since diagnosis of IBD (including those performed before knowing the patient had IBD and which led to its diagnosis), the indication for surgery and the date of surgery will be recorded. An emergency surgical procedure will be considered as any surgery performed within 24 from admission of the patient to the emergency department. An elective surgical procedure will be considered as any procedure performed subsequent to the first day of admission and by the usual surgical team.

DATA COLLECTION

Epidemiology study:

Demographic data (age, sex, smoking), family history of IBD, socioeconomic characteristics, IBD type, pattern, and location and presence of extraintestinal manifestations at diagnosis will collected from each patient. The occurrence of complications (fistulas, stenosis, abscesses), changes in disease location, treatments for IBD, surgeries for IBD, and hospital admission during the first year since diagnosis will also be recorded.

Characterization "omics" study Samples of blood, urine and stool. Date of collection and number of samples.

STUDY VISITS

  • Visit 0 (baseline): inclusion of patient in the study and collection of socioeconomic data and on diagnosis of IBD. Collection samples of blood, urine and stool.
  • Visit 1 (month 3): confirmation of IBD diagnosis and updating of data related to treatment, changes in phenotype, hospital admissions, and surgery. Collection samples of blood, urine and stool.
  • Visit 2 (month 12): confirmation of IBD diagnosis and updating of data related to treatment, changes in phenotype, hospital admissions, and surgery. Collection samples of blood, urine and stool. End of study.

Study Type

Observational

Enrollment (Actual)

376

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain, 03010
        • Hospital General Universitario de Alicante
      • Ciudad Real, Spain, 13005
        • Hospital Universitario de Ciudad Real
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Huesca, Spain, 22004
        • Hospital San Jorge
      • Las Palmas De Gran Canaria, Spain, 35020
        • Hospital Universitario de Gran Canaria Dr. Negrin
      • Madrid, Spain, 28006
        • Hospital Universitario de La Princesa
      • Murcia, Spain, 30008
        • Hospital Universitario Morale Mesenguer
      • Oviedo, Spain, 33011
        • Hospital Universitario Central de Asturias
      • Palma De Mallorca, Spain, 07010
        • Hospital Universitario Son Espases
      • Santander, Spain, 39008
        • Hospital Universitaro Marqués de Valdecilla
      • Valencia, Spain, 46026
        • Hospital Universitario y Politécnico La Fe
      • Valladolid, Spain, 47005
        • Hospital Clínico Univesitario de Valladolid
    • Barcelona
      • Terrassa, Barcelona, Spain, 08221
        • Hospital Universitario Mutua Terrasa
    • Madrid
      • Fuenlabrada, Madrid, Spain, 28942
        • Hospital Universitario de Fuenlabrada
    • Santiago De Comostela
      • Santiago De Compostela, Santiago De Comostela, Spain, 15706
        • Hospital Universitario Santiago de Compostela
    • Vizcaya
      • Galdakao, Vizcaya, Spain, 48960
        • Hospital de Galdakao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients recently diagnosed of inflammatory bowel disese who have not initiated a treatment to IBD

Description

Inclusion Criteria:

  • Male or female ≥18 years of age diagnosed of inflammatory bowel disease
  • Diagnosis of IBD according to European Crohns and Colitis Organisation (ECCO) criteria.
  • The patient must belong to the health area of one of the participating center
  • Patients who have accepted to participate in the epidemiology study
  • < 1 month since the date of the diagnosis colonoscopy

Exclusion Criteria:

  • Patients who do not belong to the health area of the participating centers
  • Patients who do not accept to participate in the study
  • Patients who have initiated a treatment to IBD
  • Patients who received a immunomodulators to treat other disease
  • Patients with a immune-mediates systemic disease
  • Patients with a active infection or a malignancy in the baseline
  • Pregnant patients or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of IBD in Spain
Time Frame: 1 year
Measure the incidence of IBD in Spain
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characteristics of patients at diagnosis of inflammatory bowel disease and resources used in the first year after diagnosis
Time Frame: 1 year
Type of IBD, extension of the IBD, severity of the IBD at diagnosis. Immunosuppressive treatments, biologic drugs, surgery, and hospital
1 year
Create a wide collection of samples
Time Frame: 1 year
Blood simple, urine simple, stool sample
1 year
Identify the molecular and cellular pathways involved with IBD development and pathogenesis.
Time Frame: 1 year
To describe the serum proteomic profile and to characterize the density and composition of serum extracellular vesicles in newly diagnosed IBD patients, aiming to identify the molecular and cellular pathways involved with IBD development and pathogenesis.
1 year
Correlate the serum proteomic profile and the density
Time Frame: 1 year
To correlate the serum proteomic profile and the density and composition of serum extracellular vesicles with IBD phenotype at diagnose and its subsequent evolution during the first year.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2017

Primary Completion (Actual)

April 1, 2020

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

September 26, 2018

First Submitted That Met QC Criteria

September 26, 2018

First Posted (Actual)

September 28, 2018

Study Record Updates

Last Update Posted (Actual)

July 29, 2020

Last Update Submitted That Met QC Criteria

July 28, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIS-2016-IBDomics

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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