RED-FLAGS Index Validation in Crohn's Disease Patients

Crohn's Disease Clinical Trial

— RED-FLAGS2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02940054
• Other study ID #: 1414
• Status: Recruiting
• Phase: N/A
• First received: October 17, 2016
• Last updated: October 21, 2016
• Start date: February 2015
• Est. completion date: March 2018

Study information

• Verified date: October 2016
• Source: Istituto Clinico Humanitas
• Contact: Silvio Danese, MD, PhD
• Email: IBDclinicaltrials[@]humanitas.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

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.

Locations

Country	Name	City	State
Italy	Humanitas Gavazzeni	Bergamo	BG

Sponsors (3)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas	IG-IBD talian Group for Inflammatory Bowel Diseases, Takeda

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensibility of the Red Flags Index	Sensibility, specificity, accuracy, positive and negative likelihood ratio measurement	at enrollment	No
Secondary	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	No
Secondary	Cut-off for Crohn's disease diagnosis	Identification of the cut-off associated with an early diagnosis of Crohn's disease	at enrollment	No