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RED-FLAGS Index Validation in Crohn's Disease Patients — RED-FLAGS2  

Crohn's Disease Clinical Trial

Official title:
Validation of the RED-FLAGS Index for Early Diagnosis of Crohn's Disease: Prospective Observational Study

Clinical Trial Summary

Observational prospective study to validate a new index for early diagnosis of Crohn's disease (CD)

Clinical Trial Description

The study will be conducted in Italian referral centers for Crohn's disease and will involve general practitioners (GPs) for RED-Flags Index validation.

The project is divided into two phases.

1. retrospective phase (4 weeks). All the general practitioners participating to the study will extrapolate from their patient's database, the total number of patients with a Crohn's disease diagnosis performed in the past. The date of diagnosis will be indicated. No other information will be provided. These data will be then analyzed to obtain, for each GP, the total number of CD diagnosed in each semester.

2. retrospective phase (6 months). GPs will administer the RED-Flags questionnaire to all patients that meet inclusion and exclusion criteria, after informed consent signature. All these patients will be then referred to the nearest referral center, to be evaluated by a gastroenterologist specialized in CD, to confirm or exclude a CD. ;

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02940054
Study type Observational
Source Istituto Clinico Humanitas
Contact Silvio Danese, MD, PhD
Email IBDclinicaltrials@humanitas.it
Status Recruiting
Phase N/A
Start date February 2015
Completion date March 2018
View Details
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