Condition category
Digestive System
Date applied
31/10/2014
Date assigned
13/11/2014
Last edited
22/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Diagnosing inflammatory bowel disease (IBD) in primary care (for example, within a GP surgery) is challenging and a diagnosis can take a long time to confirm. This delay can result in a worsening of the condition and disease outcome. Although testing for fecal Calprotectin (inflammation of the bowel) is a useful screening tool to identify patients who need endoscopy for IBD, it is not routinely used in primary care. Here, we want to test an 8-item-questionnaire, the CalproQuest, which aims to identify those patients most likely to have IBD and therefore in need of a fecal Calprotectin test. We want to know whether the CalproQuest works and whether it is feasible in primary care setting.

Who can participate?
The study consists of two parts 1 and 2, conducted by gastroenterologists and general practitioners (GPs), respectively. Patients included in part 1 of the study are referred for endoscopic evaluation to gastroenterologists specialised for IBD. Patients included in part B of the study present at their GP because of ongoing unspecific gastrointestinal symptoms (abdominal pain, bloating, stool irregularities, diarrhea) for at least two weeks.

What does the study involve?
Part 1: Patients fill out the CalproQuest questionnaire and their stool is tested for Calprotectin. They then undergo a endoscopic examination. Eventually, patients diagnosed with IBD will be asked to complete a questionnaire investigating how long it took for the diagnosis to be confirmed.
Part 2: Patients going to their GP with ongoing unspecific gastrointestinal symptoms for more than two weeks are asked to fill in the CalproQuest and provide stool samples for Calprotectin testing. Patients who have high Calprotectin levels are referred to a gastroenterologist for endoscopic examination. The results are then sent back to the GP. Patients are then asked to complete a questionnaire on acceptance of stool sampling, and physicians will complete the questionnaire on the feasibility of using CalproQuest in daily practice.

What are the possible benefits and risks to participating?
The patients have the benefit of a systematic questionnaire with key questions addressing early symptoms of IBD. In Part 1 an endoscopy is performed, but on patients that have already been referred for endoscopic evaluation. Therefore, no additional risks are expected.

Where is the study conducted?
The University of Zurich (Switzerland).

When is the study starting and how long is it expected to run for?
October 2014 to March 2016.

Who is funding the study?
1. Institute for Primary Care – University of Zurich (Institut für Hausarztmedizin der Universität Zürich) (Switzerland)
2. IBDnet (Switzerland)

Who is the main contact?
Prof. Dr. med. Thomas Rosemann, PhD
thomas.rosemann@usz.ch

Trial website

Contact information

Type

Scientific

Primary contact

Dr Susann Hasler

ORCID ID

Contact details

Institute of Primary Care
University Hospital of Zurich
Pestalozzistrasse 24
Zürich
8091
Switzerland
+41 52 266 37 50
susann.hasler@usz.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

ALERT: VAlidation of an 8-item questionnaire predictive for a positive CaLprotectin tEst and Real-life implemenTation in primary care to reduce diagnostic delay in inflammatory bowel disease: a prospective diagnostic observational trial

Acronym

ALERT

Study hypothesis

This study pursuits two main aims A and B, which are investigated independently:
1. Prospective validation and evaluation of sensitivity and specificity of an 8-item inflammatory-bowel-disease(IBD)-questionnaire (CalproQuest) for 1) a positive Calprotectin test result 50 μg/g feces and for 2) a positive Calprotectin test result 50 μg/g feces and positive IBD-diagnosis, respectively, in tertiary care
2. Prospective implementation of CalproQuest in primary care to investigate feasibility in daily practice

Ethics approval

The ethics board of the Canton Zurich (Kantonale Ethik-Kommission Zürich), 25/06/2014, ref. KEK-ZH-Nr. 2013-0516

Study design

Prospective diagnostic observational trial

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Other

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Immune bowel disease

Intervention

1. Investigation of the sensitivity and specificity of CalproQuest for stool Calprotectin levels ≥ 50 μg/g feces and for positive IBD diagnosis:
Patients referred to the gastroenterologist for endoscopic examination are subjected to CalproQuest and Calprotectin stool testing prior endoscopy. At baseline T0, patients will be subjected to CalproQuest. Subsequently, at T1 fecal samples will be obtained to measure Calprotectin levels. The patients themselves will perform collection of the fecal specimens. The fecal specimens from outpatients will be shipped to the laboratory at the University Hospital Zurich by mail. After measurement, fecal samples will be disposed according to current guidelines. At T2, endoscopic examination will be performed to obtain a diagnosis. Eventually, patients diagnosed with IBD will be asked to complete a questionnaire at T3 investigating duration of first onset of symptoms to IBD diagnosis (diagnostic delay).
2. Investigation of feasibility of CalproQuest in daily primary care practice
Patients with on-going unspecific gastrointestinal symptoms (abdominal pain, bloating, stool irregularities, diarrhea) for more than two weeks presenting at the GP will be included into the study if all inclusion criteria are met and informed patient consent is obtained. At baseline (T0), patients will be subjected to CalproQuest. Subsequently, at T1 fecal samples will be obtained to measure Calprotectin levels. The patients themselves will perform collection of the fecal specimens. The fecal specimens will be shipped to the laboratory at the University Hospital Zurich by mail. After measurement, fecal samples will be disposed according to current guidelines. According to the current standard of care it is recommended to refer patients with Calprotectin levels ≥ 50 μg/g to a gastroenterologist for endoscopic examination at T2; results of the endoscopy are communicated back to the GP. Patients will be asked at T3 to complete a questionnaire on acceptance of stool sampling, and physicians will complete the questionnaire on feasibility of CalproQuest in daily practice.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Part 1:
1.1. Sensitivity and specificity of CalproQuest for a positive Calprotectin test result 50 μg/g feces
1.2. Sensitivity and specificity of CalproQuest for a positive Calprotectin test result 50 μg/g feces and positive IBD-diagnosis.
Part 2:
2.1 Feasibility of CalproQuest in daily primary care practice

Timepoints:
Part 1: Sensitivity and specificity (primary outcomes) will be measured 12 months after recruiting the last study centre (part 1: IBD-centre, part 2: GP) or earlier, when the target number of patients (part 1: 162, part 2: 80) has been achieved.
Part 2: Feasibility of CalproQuest in daily primary care practice will be measured after the announcement of the Calprotectin test result, not exceeding 2 weeks after the consultation at the gastroenterologist or GP.

Secondary outcome measures

Part 1: Patient-reported diagnostic delay.
Part 2: Patient acceptance of stool sampling.

Timepoints:
Part 1: Patient-reported diagnostic delay after the endoscopy exam, the whole procedure between first consultation and endoscopy will take at most 2 months.
Part 2: Patient acceptance of stool sampling directly after fecal samples will be obtained at home (not exceeding 2 weeks after the consultation at the gastroenterologist or GP).

Overall trial start date

14/10/2014

Overall trial end date

31/03/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Are aged at least 18 years (part 1, 2)
2. Are referred to their gastroenterologist for any endoscopic examination (part 1)
3. Visit their GP because of on-going unspecific gastrointestinal symptoms (abdominal pain, bloating, stool irregularities, diarrhea) for at least two weeks (part 2)
4. Underwent no earlier diagnostic procedures (endoscopy) for the current episode (part 2)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

162 patients in part 1, 80 patients in part 2

Participant exclusion criteria

1. Are younger than 18 years (part 1, 2)
2. Have known further /other abdominal pathologies as e.g. cancer (part 1, 2)
3. Had previous abdominal surgeries (part 2)
4. Have been treated with steroids (topical and/or oral) and/or aminosalicylates within 30 days prior inclusion into this study (part 2)
5. Underwent endoscopic examination within 3 years prior screening (part 2)

Recruitment start date

14/10/2014

Recruitment end date

31/03/2016

Locations

Countries of recruitment

Switzerland

Trial participating centre

Institute of Primary Care
Zürich
8091
Switzerland

Sponsor information

Organisation

University Hospital of Zurich (Switzerland)

Sponsor details

c/o Prof. Dr. med. Thomas Rosemann
Institute of Primary Care
Pestalozzistrasse 24
Zürich
8091
Switzerland
+41 44 255 90 99
thomas.rosemann@usz.ch

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Institute for Primary Care – University of Zurich (Institut für Hausarztmedizin der Universität Zürich) (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

IBDnet (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 protocol in http://www.ncbi.nlm.nih.gov/pubmed/25757949

Publication citations

Additional files

Editorial Notes

22/12/2015: Publication reference added.