NCT02940054

RED-FLAGS Index Validation in Crohn's Disease Patients

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
OTHER	Red-flags questionnaire	A questionnaire composed by 8 items will be administered by GPs to those patients and they will be referred to a gastroenterologist with expertise in CD. All those patients will be evaluated, as per usual practice, to confirm or exclude Crohn's disease.

Timeline

• Start date: 2015-02-01
• Primary completion: 2017-12-01
• Completion: 2018-03-01
• First posted: 2016-10-20
• Last updated: 2016-10-24

Locations

1 site across 1 country: Italy