RED-FLAGS Index Validation in Crohn's Disease Patients

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

Detailed Description
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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. 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. 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.

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

Conditions
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Crohn's Disease

Intervention / Treatment
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* Other: Red-flags questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least one of the following symptoms, for at least 4 weeks (either continuous or intermittent) diarrhea (>3 bowel movements per day) nocturnal diarrhea weight loss (≥5% of usual body weight) abdominal pain (chronic or intermittent) perianal lesions or fistulae or perianal abscess (hemorrhoidal diseases excluded) 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: known diagnosis of Crohn's disease, ulcerative colitis, chronic diverticulosis or any other gastrointestinal disease any clinical condition that, in the opinion of the investigator, can alter stud results inability to understanding and complying with protocol requirements informed consent not signed and dated by the subject

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patents with suspected Crohn's disease<br>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. | Other: Red-flags questionnaire<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensibility of the Red Flags Index | Sensibility, specificity, accuracy, positive and negative likelihood ratio measurement | at enrollment | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early diagnosis