Crohn's DiseaseRED-FLAGS2NCT02940054
RED-FLAGS Index Validation in Crohn's Disease Patients
An observational study of Crohn's Disease, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
Observational prospective study to validate a new index for early diagnosis of Crohn's disease (CD) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Red-flags questionnaire
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2015to Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 600 subjects, aged 18-65, requiring general practitioner's advise for gastrointestinal symptoms compatible with Crohn's disease.
Who may be able to join
- at least one of the following symptoms, for at least 4 weeks (either continuous or intermittent)
- diarrhea (>3 bowel movements per day)
- nocturnal diarrhea
- weight loss (≥5% of usual body weight)
- abdominal pain (chronic or intermittent)
- perianal lesions or fistulae or perianal abscess (hemorrhoidal diseases excluded)
- 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.
Who cannot join
- known diagnosis of Crohn's disease, ulcerative colitis, chronic diverticulosis or any other gastrointestinal disease
- any clinical condition that, in the opinion of the investigator, can alter stud results
- inability to understanding and complying with protocol requirements
- informed consent not signed and dated by the subject
Trial locations and contacts
1 site in 1 country.
Silvio Danese, MD, PhD contact
About this study
Official title: 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)
Read the 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.
- 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.
- 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
- Being tested
- Red-flags questionnaire
- Keywords
- Early diagnosis
- Medical subject headings
- Crohn Disease, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red-flags questionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Red-flags questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensibility of the Red Flags Index
Sensibility, specificity, accuracy, positive and negative likelihood ratio measurement
Measured: at enrollment
Secondary outcomes (2)
Percentage of early diagnosed
Percentage of early diagnosed of Crohn's Disease in the 6 months of prospective use of the tool
Measured: 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
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study startFeb 2015
- Primary completionDec 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda, IG-IBD talian Group for Inflammatory Bowel Diseases
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940054
- Sponsor's protocol ID
- 1414
- Acronym
- RED-FLAGS2
- Status last verified
- Oct 2016
- First submitted
- 17 Oct 2016
- Last updated
- 24 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 25908718
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the RED-FLAGS Index for Early Diagnosis of Crohn's Disease: Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02940054
- Acronym / sponsor ID
- RED-FLAGS2 / 1414
- Conditions
- Crohn's Disease
- Keywords
- Early diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Collaborators
- Takeda, IG-IBD talian Group for Inflammatory Bowel Diseases
- Study start
- Feb 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 20 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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 design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patents with suspected Crohn's disease | – | Other: Red-flags questionnaireAdult 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 600 subjects, aged 18-65, requiring general practitioner's advise for gastrointestinal symptoms compatible with Crohn's disease.
Key inclusion criteria (7 listed)
- at least one of the following symptoms, for at least 4 weeks (either continuous or intermittent)
- 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.
Key exclusion criteria (4 listed)
- known diagnosis of Crohn's disease, ulcerative colitis, chronic diverticulosis or any other gastrointestinal disease
- any clinical condition that, in the opinion of the investigator, can alter stud results
- inability to understanding and complying with protocol requirements
- informed consent not signed and dated by the subject
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red-flags questionnaireA 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. | Other | Patents with suspected Crohn's disease |
Primary outcome
Sensibility of the Red Flags Index
Time frame: at enrollment
Sensibility, specificity, accuracy, positive and negative likelihood ratio measurement
2 secondary outcomes
Percentage of early diagnosed
Time frame: 6 months of prospective period
Cut-off for Crohn's disease diagnosis
Time frame: at enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
- Background: PubMed 25908718Danese 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvio Danese, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvio Danese, MD, PhD (IBDclinicaltrials@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensibility of the Red Flags Index (time frame: at enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02940054, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2016.