EURECA (EUropeanRElapseCAlprotectin) Study

EURECA (EUropeanRElapseCAlprotectin) Study - Calprotectin as Prediction Marker of Relapse in Patients With Quiescent Ulcerative Colitis

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases
• Intervention / Treatment: Diagnostic test: LIAISON Calprotectin

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)

• Study Type: Interventional
• Enrollment (Actual): 225
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nancy, France
    • Centre Hospitalier Universitaire De Nancy (CHU de Nancy) Department Gastroenterology
• Italy
  • Milan, Italy
    • Istituto Clinico Humanitas Centro IBD Diparimento di Gastroenterologia
• Spain
  • Barcelona, Spain
    • Centro Médico Teknon Gastroenterologia Adultos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Ulcerative colitis in clinical and endoscopic remission; Patients with established diagnosis of ulcerative colitis (UC) in clinical and endoscopic remission defined as clinical score = 0 at enrollment with no endoscopy flare up may participate to follow up. Proctosigmoidoscopy to document endoscopic remission has to be foreseen. The patients' inclusion/exclusion criteria are based on the established diagnostic procedures for the UC, i.e. colonoscopy at the time of diagnosis, endoscopic evidence of remission and clinical significant findings.

Diagnostic test: LIAISON Calprotectin; Immunoassay for fecal calprotectin measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Sensitivity and 95% Confidence Interval (exact method)	Computed and compared to the clinical diagnosis	Through study completion, an average of 36 months
Clinical Specificity and 95% Confidence Interval (exact method)	Computed and compared to the clinical diagnosis	Through study completion, an average of 36 months
Positive Predictive Value and 95% Confidence Interval (exact method)	Computed and compared to the clinical diagnosis	Through study completion, an average of 36 months
Kaplan-Meier survival curve	Percent variation from one time point to the following one will computed and compared to the disease evolution determined by the clinician for each subject. This curve will be used to determine the ability of the calprotectin value at the time of subject recruitment to predict the relapse.	Through study complete, an average of 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ROC Analysis and the relevant plots	Analysis will determine if the assay was assigned with appropriate cut-off value	Through study completion, an average of 36 months

Collaborators and Investigators

• Sponsor: DiaSorin Inc.
• Investigators: Study Director: Alberto Malesci, Professor, Istituto Clinico Humanitas, Head of Gastroenterology Department

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2017
• Primary Completion (Actual): January 13, 2020
• Study Completion (Actual): January 13, 2020

Study Registration Dates

• First Submitted: December 10, 2021
• First Submitted That Met QC Criteria: December 10, 2021
• First Posted (Actual): December 23, 2021

Study Record Updates

• Last Update Posted (Actual): January 6, 2022
• Last Update Submitted That Met QC Criteria: January 5, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases
• Other Study ID Numbers: CLI-PR-1601

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes