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EURECA (EUropeanRElapseCAlprotectin) Study

Primary Purpose

Inflammatory Bowel Diseases

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

LIAISON Calprotectin

About this trial

This is an interventional diagnostic trial for Inflammatory Bowel Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre Hospitalier Universitaire De Nancy (CHU de Nancy) Department Gastroenterology
Istituto Clinico Humanitas Centro IBD Diparimento di Gastroenterologia
Centro Médico Teknon Gastroenterologia Adultos

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Ulcerative colitis in clinical and endoscopic remission

Arm Description

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.

Outcomes

Primary Outcome Measures

Clinical Sensitivity and 95% Confidence Interval (exact method)

Computed and compared to the clinical diagnosis

Clinical Specificity and 95% Confidence Interval (exact method)

Computed and compared to the clinical diagnosis

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

Computed and compared to the clinical diagnosis

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.

Secondary Outcome Measures

ROC Analysis and the relevant plots

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

Full Information

NCT ID

NCT05168917

First Posted

December 10, 2021

Last Updated

January 5, 2022

Sponsor

DiaSorin Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05168917

Brief Title

EURECA (EUropeanRElapseCAlprotectin) Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

June 2, 2017 (Actual)

Primary Completion Date

January 13, 2020 (Actual)

Study Completion Date

January 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

DiaSorin Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammatory Bowel Diseases

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

225 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ulcerative colitis in clinical and endoscopic remission

Arm Type

Other

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

LIAISON Calprotectin

Intervention Description

Immunoassay for fecal calprotectin measurement

Primary Outcome Measure Information:

Title

Clinical Sensitivity and 95% Confidence Interval (exact method)

Description

Computed and compared to the clinical diagnosis

Time Frame

Through study completion, an average of 36 months

Title

Clinical Specificity and 95% Confidence Interval (exact method)

Description

Computed and compared to the clinical diagnosis

Time Frame

Through study completion, an average of 36 months

Title

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

Description

Computed and compared to the clinical diagnosis

Time Frame

Through study completion, an average of 36 months

Title

Kaplan-Meier survival curve

Description

Time Frame

Through study complete, an average of 36 months

Secondary Outcome Measure Information:

Title

ROC Analysis and the relevant plots

Description

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

Time Frame

Through study completion, an average of 36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alberto Malesci, Professor

Organizational Affiliation

Istituto Clinico Humanitas, Head of Gastroenterology Department

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Nancy

Country

France

Facility Name

Istituto Clinico Humanitas Centro IBD Diparimento di Gastroenterologia

City

Milan

Country

Italy

Facility Name

Centro Médico Teknon Gastroenterologia Adultos

City

Barcelona

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

35789124

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.

Results Reference

derived

Learn more about this trial

EURECA (EUropeanRElapseCAlprotectin) Study

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