RED-FLAGS Index Validation in Crohn's Disease Patients

NCT ID: NCT02940054

Last Updated: 2016-10-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2018-03-31

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.

Conditions

Crohn's Disease

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Red-flags questionnaire

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: collaborator

IG-IBD talian Group for Inflammatory Bowel Diseases

UNKNOWN

Sponsor Role: collaborator

Istituto Clinico Humanitas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Humanitas Gavazzeni

Bergamo, BG, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Silvio Danese, MD, PhD

Role: CONTACT

IBDclinicaltrials@humanitas.it

References

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.

Reference Type: BACKGROUND

PMID: 25908718 (View on PubMed)

Other Identifiers

1414

Identifier Type: -

Identifier Source: org_study_id