Asymptomatic Inflammatory Bowel Disease in Catalonia

March 10, 2021 updated by: Anna Selva, Corporacion Parc Tauli

Asymptomatic Inflammatory Bowel Disease Diagnosed During the Colorectal Cancer Population Screening un Catalonia

An early treatment of inflammatory bowel disease (IBD) has been proposed to correlate to better outcomes. In Catalonia the screening programme was implemented in all the territory in 2015. The aim of this study is to describe the natural history of the asymptomatic IBD detected during colorectal cancer population screening.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This study will be performed and reported according to the STROBE Statement guidelines ( http://www.strobe-statement.org/index.php?id=strobe-home).

Design:

Observational, multicentre and retrospective cohort study.

Centre selection and recruitment:

All the participating centres in population colorectal cancer screening in Catalonia will be invited. All the participating centres must certify the approval of the protocol in their ethical committees.

Study population:

All patients with asymptomatic IBD diagnosed during the population colorectal cancer screening in the Catalonian colorectal screening program within the period 2000 to 2019 will be included.

Study variables

Prevalence of asymptomatic IBD diagnosed and their evolution through the years will be described. The following variables will be collected (annex1):

  • Sex (male, female)
  • Age
  • Fecal immunotest (value)
  • Date of screening colonoscopy (yyyy/mm/dd)
  • Ileoscopy performed (yes/no)
  • Type of IBD (CD, UC, indeterminate colitis)
  • Endoscopic findings: mild-moderate activity or severe activity for CD and Mayo score for UC (value of the scores).
  • Montreal classification (value of the classification)
  • Histology (diagnostic, compatible, unspecific or no compatible)
  • Microscopic description (cryptitis, abscess, mucus depletion, granuloma, architectural pattern alteration
  • Past medical history, smoking habit, previous abdominal surgeries and comorbidities.
  • Familiar history of IBD
  • Extraintestinal manifestations (cutaneous, ophthalmologic, articular)
  • Other studies performed (endoscopic capsule, MRI, gastroscopy, echography).
  • Calprotectin: value of the first analysis in the outpatient visit.
  • Blood test: Haemoglobin, ferritin and PCR: values of the first analysis in the outpatient visit.
  • Fist symptom: none, change in depositional rhythm, abdominal pain, weight loss, rectal urgency, anal pain, iron deficiency anaemia.
  • Date of first IBD symptom (yyyy/mm/dd)
  • Time to first IBD symptom: time in days from the diagnosis of IBD.
  • Treatments used: none; 5- aminosalicylates, corticosteroids, non-biologic immunosuppressive treatment, biologic treatment, surgery
  • Treatment start and end date (yyyy/mm/dd)
  • Time to first treatment: time in days from the diagnosis of IBD.
  • Follow-up endoscopy: Date (yyyy/mm/dd) and activity.

Data collection:

All patients with asymptomatic IBD diagnosed during the population colorectal cancer screening within the period 2000 to 2019 will be identified by the colorectal cancer screening program registry.

Patient identity will be given to a data manager. This manager will administrate the data of each patient in their hospital.

The person in charge of the study in each hospital will collect the anonymized data using REDCap database (Research Electronic Data Capture), a secure, web-based application designed to support data collection form research studies.

Statistical methods:

Categorical variable will be given as natural frequencies and percentages and quantitative variables will be given as mean or median and standard deviation or interquartile ranges. Kaplan-Meier analysis will be used to describe the time to first symptom and or time to first treatment. If necessary, the long rank test will be used to compare survival curves. A multivariate Cox analysis will be performed to ascertain the independent predictors of aggressive disease.

Ethical issues:

The research will use retrospective anonymized data from the technical screening office of Catalonia. No personal data will be used, and all the patient data will be encrypted, so that no personal identification would be retrievable or traceable to the original source from the working database.

All the researchers who collaborate in the study will sign a commitment document in which their functions and obligations will be defined. Both in the collection of data and in the analysis, Organic Law 3/2018, of December 5, on the Protection of Personal Data and guarantee of digital rights and the provisions of European Regulation 679/2016 will be followed.

The study was revised and approved by the local ethics committee of the Hospital universitarian Parc Tauli in Sabadell (CEIC 2021/5006) on 15 February 2021. The study will comply with the ethical guidelines of the Declaration of Helsinki. Therefore, as the study uses retrospective anonymized data and it has no impact on evolution or treatment patient, there is no need to obtain informed consent. The study will be performed in accordance with the STROBE statement for reporting observational studies in Epidemiology.

Study Type

Observational

Enrollment (Anticipated)

200

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
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Corporacio Sanitaria Parc Tauli

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

Probability Sample

Study Population

Centre selection and recruitment:

All the participating centres in population colorectal cancer screening in Catalonia will be invited. All the participating centres must certify the approval of the protocol in their ethical committees.

Study population:

All patients with asymptomatic IBD diagnosed during the population colorectal cancer screening in the Catalonian colorectal screening program within the period 2000 to 2019 will be included.

Description

Inclusion Criteria:

  • All patients with asymptomatic IBD diagnosed during the population colorectal cancer screening in the Catalonian colorectal screening program within the period 2000 to 2019 will be included.

Exclusion Criteria:

  • Symptoms in the first outpatient visit.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Asymptomatic IBD diagnosed during the colorectal cancer screening
Diagnostic test: Colorectal cancer screening
Patients with IBP diagnosed during the colorectal cancer screening

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to treatment
Time Frame: From date of diagnosis until the date of first treatment, assessed up to 19 years.
To see the evolution of the asymptomatic IBD and the need for the treatment
From date of diagnosis until the date of first treatment, assessed up to 19 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to symptoms
Time Frame: From date of diagnosis until the date of first symptom, assessed up to 19 years.
To see the evolution of the asymptomatic IBD and the symptomatology
From date of diagnosis until the date of first symptom, assessed up to 19 years.

Collaborators and Investigators

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

Sponsor

Corporacion Parc Tauli

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 (Anticipated)

April 1, 2021

Primary Completion (Anticipated)

July 15, 2021

Study Completion (Anticipated)

October 31, 2021

Study Registration Dates

First Submitted

March 7, 2021

First Submitted That Met QC Criteria

March 10, 2021

First Posted (Actual)

March 12, 2021

Study Record Updates

Last Update Posted (Actual)

March 12, 2021

Last Update Submitted That Met QC Criteria

March 10, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/5006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

Clinical Trials on Inflammatory Bowel Diseases

Clinical Trials on Colorectal cancer screening

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe