EURECA (EUropeanRElapseCAlprotectin) Study

DiaSorin Inc.225 enrolled

Overview

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.

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

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

225

Conditions

Inflammatory Bowel Diseases

Interventions

LIAISON CalprotectinDIAGNOSTIC_TEST

Immunoassay for fecal calprotectin measurement

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Centre Hospitalier Universitaire De Nancy (CHU de Nancy) Department Gastroenterology

Nancy, France

Istituto Clinico Humanitas Centro IBD Diparimento di Gastroenterologia

Milan, Italy

Centro Médico Teknon Gastroenterologia Adultos

Barcelona, Spain

Outcomes

Primary Outcomes

Clinical Sensitivity and 95% Confidence Interval (exact method)

Computed and compared to the clinical diagnosis

Time frame: Through study completion, an average of 36 months

Clinical Specificity and 95% Confidence Interval (exact method)

Computed and compared to the clinical diagnosis

Time frame: Through study completion, an average of 36 months

Positive Predictive Value and 95% Confidence Interval (exact method)

Computed and compared to the clinical diagnosis

Time frame: 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.

Time frame: Through study complete, an average of 36 months

Secondary Outcomes

ROC Analysis and the relevant plots

Analysis will determine if the assay was assigned with appropriate cut-off value

Time frame: Through study completion, an average of 36 months

Data from ClinicalTrials.gov

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