EURECA (EUropeanRElapseCAlprotectin) Study

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05168917
• Other study ID #: CLI-PR-1601
• Status: Completed
• Phase: N/A
• Start date: June 2, 2017
• Est. completion date: January 13, 2020

Study information

• Verified date: January 2022
• Source: DiaSorin Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: January 13, 2020
• Est. primary completion date: January 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases

Intervention

Diagnostic Test:
• LIAISON Calprotectin
Immunoassay for fecal calprotectin measurement

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
DiaSorin Inc.

Countries where clinical trial is conducted

France,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Sensitivity and 95% Confidence Interval (exact method)	Computed and compared to the clinical diagnosis	Through study completion, an average of 36 months
Primary	Clinical Specificity and 95% Confidence Interval (exact method)	Computed and compared to the clinical diagnosis	Through study completion, an average of 36 months
Primary	Positive Predictive Value and 95% Confidence Interval (exact method)	Computed and compared to the clinical diagnosis	Through study completion, an average of 36 months
Primary	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	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