NCT04794465

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 12, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

March 12, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

March 7, 2021

Last Update Submit

March 10, 2021

Conditions

Keywords

inflammatory bowel diseaseepidemiology

Outcome Measures

Primary Outcomes (1)

  • Time to treatment

    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 Outcomes (1)

  • Time to symptoms

    From date of diagnosis until the date of first symptom, assessed up to 19 years.

Study Arms (1)

Asymptomatic IBD diagnosed during the colorectal cancer screening

Diagnostic Test: Colorectal cancer screening

Interventions

Patients with IBP diagnosed during the colorectal cancer screening

Asymptomatic IBD diagnosed during the colorectal cancer screening

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • Symptoms in the first outpatient visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Corporació Sanitària Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
15 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Epidemiology and Cancer Screening, Corporació Sanitària Parc Taulí, Sabadell, Spain

Study Record Dates

First Submitted

March 7, 2021

First Posted

March 12, 2021

Study Start

April 1, 2021

Primary Completion

July 15, 2021

Study Completion

October 31, 2021

Last Updated

March 12, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations