RED-FLAGS Index Validation in Crohn's Disease Patients

• Conditions: Crohn's Disease
• Interventions: Other: Red-flags questionnaire

• Registration Number: NCT02940054
• Lead Sponsor: Istituto Clinico Humanitas

Brief 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.

Study Timeline

• Study Start: 2015-02
• Status Verified: 2016-10
• Study First Submitted: 2016-10-17
• Study First Submitted QC: 2016-10-18
• Study First Posted: 2016-10-20
• Last Update Submitted: 2016-10-21
• Last Update Posted: 2016-10-24
• Primary Completion: 2017-12
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. at least one of the following symptoms, for at least 4 weeks (either continuous or intermittent)

   1. diarrhea (>3 bowel movements per day)
   2. nocturnal diarrhea
   3. weight loss (≥5% of usual body weight)
   4. abdominal pain (chronic or intermittent)
   5. perianal lesions or fistulae or perianal abscess (hemorrhoidal diseases excluded)

2. In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements. The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.

Exclusion Criteria

1. known diagnosis of Crohn's disease, ulcerative colitis, chronic diverticulosis or any other gastrointestinal disease
2. any clinical condition that, in the opinion of the investigator, can alter stud results
3. inability to understanding and complying with protocol requirements
4. informed consent not signed and dated by the subject

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patents with suspected Crohn's disease	Red-flags questionnaire	Adult patients showing at least one of the following symptoms, from at least 4 weeks: * diarrhea * nocturnal diarrhea * body weight loss (\>5%) * abdominal pain * perianal lesions.

Primary Outcome Measures

Name	Time	Method
Sensibility of the Red Flags Index	at enrollment	Sensibility, specificity, accuracy, positive and negative likelihood ratio measurement

Secondary Outcome Measures

Name	Time	Method
Cut-off for Crohn's disease diagnosis	at enrollment	Identification of the cut-off associated with an early diagnosis of Crohn's disease
Percentage of early diagnosed	6 months of prospective period	Percentage of early diagnosed of Crohn's Disease in the 6 months of prospective use of the tool

Trial Locations

Locations (1)

Humanitas Gavazzeni; 🇮🇹 Bergamo, BG, Italy