RED-FLAGS Index Validation in Crohn's Disease Patients (RED-FLAGS2)

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

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

Study Overview

• Status: Unknown
• Conditions: Crohn's Disease
• Intervention / Treatment: Other: Red-flags questionnaire

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 Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Silvio Danese, MD, PhD; Email: IBDclinicaltrials@humanitas.it

Study Locations

• Italy
  • BG
    • Bergamo, BG, Italy
      • Recruiting
      • Humanitas Gavazzeni

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patents with suspected Crohn's disease; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas
• Collaborators: Takeda; IG-IBD talian Group for Inflammatory Bowel Diseases

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: October 17, 2016
• First Submitted That Met QC Criteria: October 18, 2016
• First Posted (Estimate): October 20, 2016

Study Record Updates

• Last Update Posted (Estimate): October 24, 2016
• Last Update Submitted That Met QC Criteria: October 21, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Early diagnosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 1414