Clinical trial NCT02940054: RED-FLAGS Index Validation in Crohn's Disease Patients
Official title: Validation of the RED-FLAGS Index for Early Diagnosis of Crohn's Disease: Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Crohn's Disease
Keywords: Early diagnosis
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
Collaborators: name: Takeda
name: IG-IBD talian Group for Inflammatory Bowel Diseases
First posted: 2016-10-20
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 600 subjects, aged 18-65, requiring general practitioner's advise for gastrointestinal symptoms compatible with Crohn's disease.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensibility of the Red Flags Index
timeFrame: at enrollment
Secondary outcomes:
measure: Percentage of early diagnosed
timeFrame: 6 months of prospective period
measure: Cut-off for Crohn's disease diagnosis
timeFrame: at enrollment
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Humanitas Gavazzeni
state: BG
Study officials:
References:
citation: Danese S, Fiorino G, Mary JY, Lakatos PL, D'Haens G, Moja L, D'Hoore A, Panes J, Reinisch W, Sandborn WJ, Travis SP, Vermeire S, Peyrin-Biroulet L, Colombel JF. Development of Red Flags Index for Early Referral of Adults with Symptoms and Signs Suggestive of Crohn's Disease: An IOIBD Initiative. J Crohns Colitis. 2015 Aug;9(8):601-6. doi: 10.1093/ecco-jcc/jjv067. Epub 2015 Apr 23.