EURECA (EUropeanRElapseCAlprotectin) Study

NCT05168917 | Completed FDA Device

• 1 other identifier: CLI-PR-1601
• Study Type: interventional
• Target: 225
• Locations: 3 countries
• Sites: 3

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.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• ROC Analysis and the relevant plots

  Through study completion, an average of 36 months

Study Arms (1)

Ulcerative colitis in clinical and endoscopic remission

OTHER

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

Interventions

LIAISON Calprotectin DIAGNOSTIC_TEST

Immunoassay for fecal calprotectin measurement

Ulcerative colitis in clinical and endoscopic remission

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• DiaSorin Inc.: lead

Study Sites (3)

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

Nancy, France

Location

Istituto Clinico Humanitas Centro IBD Diparimento di Gastroenterologia

Milan, Italy

Location

Centro Médico Teknon Gastroenterologia Adultos

Barcelona, Spain

Location

Related Publications (1)

• 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.

  PMID: 35789124 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Alberto Malesci, Professor

  Istituto Clinico Humanitas, Head of Gastroenterology Department

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Basal visit and follow up visits at 3,9,and 18 months in which stool specimens wil be collected.

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: December 23, 2021
• Study Start: June 2, 2017
• Primary Completion: January 13, 2020
• Study Completion: January 13, 2020
• Last Updated: January 6, 2022

Record last verified: 2022-01

Locations

FR (1); IT (1); ES (1)