Clinical trial NCT05168917: EURECA (EUropeanRElapseCAlprotectin) Study
Official title: EURECA (EUropeanRElapseCAlprotectin) Study - Calprotectin as Prediction Marker of Relapse in Patients With Quiescent Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Lead sponsor: DiaSorin Inc.
Sponsor class: INDUSTRY
First posted: 2021-12-23
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Basal visit and follow up visits at 3,9,and 18 months in which stool specimens wil be collected.
Primary purpose: DIAGNOSTIC

Brief summary: This study will investigate the correlation of fecal calprotectin (FC) values to quiescent ulcerative colitis and to disease activity (relapse) as assessed by clinical data and endoscopy.

Detailed description: The study is prospective with a longitudinal approach. About 200 patients will be followed every 3 to 12 months (at basal, 3, 6, 9 and 12 months alternating visits to telephone contacts) and subsequently for further 6 months in 3 different sites (competitive enrollment, 1site/country, Italy, France and Spain respectively). Fecal samples for immunoassays will be collected at follow up visits, stored frozen (-20°C) and sent to testing lab for their determination.

The following assessments are foreseen:

Clinical history and demography (screening), Proctosigmoidoscopy (basal), Hemochromo with WBC differential count, C-reactive protein (every 6 months from screening up to 12 months; relapse), Coagulation (screening) Specimen collection for fecal calprotectin determination (within 1-2 weeks from Informed Consent signature; for basal time point; every next 3 months from basal up to 12 months and at month 18; relapse), Coproculture for Salmonella, Shigella, E. Coli and Campylobacter (relapse), Pharmacological ongoing therapy, Mayo score (each time point; relapse)

Eligibility criteria: Inclusion Criteria:

* Adults,18 years and older, either genders
* Subject previously diagnosed with left-sided colitis or pancolitis based on endoscopy and, if available, confirmed by histological examination of biopsy taken during endoscopy
* Subject in clinical and endoscopic remission. Remission will be documented by proctosigmoidoscopy.
* Subject who may receive maintenance therapy as per current medical practice, e.g. mesalazine, corticosteroids, azathioprine, anti-TNF
* Availability of stool specimen for basal time point
* Subject willing and able to sign, the approved Informed Consent Form for this project in accordance with international and national regulations
* Subject able to understand and follow study procedures

Exclusion Criteria:

* Any subject that does not meet the inclusion criteria
* Subject with microscopic colitis
* Subject with Crohn's disease
* Subject with limited proctitis
* Subject with severe chronic disease affecting the possibility to comply with the study protocol (i.e. severe cardiovascular disease, renal or liver failure, neurologic disease, hematological disease and mental disorder)
* Subject who is regularly taking oral anticoagulants
* Subject who is currently pregnant or lactating
* Subject unable or unwilling to subscribe informed consent
* Subject unable or unwilling to perform required study procedures

Primary outcomes:
measure: Clinical Sensitivity and 95% Confidence Interval (exact method)
timeFrame: Through study completion, an average of 36 months
measure: Clinical Specificity and 95% Confidence Interval (exact method)
timeFrame: Through study completion, an average of 36 months
measure: Positive Predictive Value and 95% Confidence Interval (exact method)
timeFrame: Through study completion, an average of 36 months
measure: Kaplan-Meier survival curve
timeFrame: Through study complete, an average of 36 months
Secondary outcomes:
measure: ROC Analysis and the relevant plots
timeFrame: Through study completion, an average of 36 months
Other outcomes:
Locations:
city: Nancy
country: France
facility: Centre Hospitalier Universitaire De Nancy (CHU de Nancy) Department Gastroenterology
city: Milan
country: Italy
facility: Istituto Clinico Humanitas Centro IBD Diparimento di Gastroenterologia
city: Barcelona
country: Spain
facility: Centro Médico Teknon Gastroenterologia Adultos
Study officials:
affiliation: Istituto Clinico Humanitas, Head of Gastroenterology Department
name: Alberto Malesci, Professor
role: STUDY_DIRECTOR
References:
citation: Fiorino G, Danese S, Peyrin-Biroulet L, Sans M, Bonelli F, Calleri M, Zierold C, Pollastro R, Moretti F, Malesci A. LIAISON(R) Calprotectin for the prediction of relapse in quiescent ulcerative colitis: The EuReCa study. United European Gastroenterol J. 2022 Oct;10(8):836-843. doi: 10.1002/ueg2.12268. Epub 2022 Jul 4.