Crohn's Disease
Conditions
Keywords
Early diagnosis
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.
Interventions
OTHERRed-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.
Sponsors
Takeda
IG-IBD talian Group for Inflammatory Bowel Diseases
Istituto Clinico Humanitas
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensibility of the Red Flags Index | at enrollment | Sensibility, specificity, accuracy, positive and negative likelihood ratio measurement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Contacts
Primary ContactSilvio Danese, MD, PhD
Outcome results
None listed