EURECA (EUropeanRElapseCAlprotectin) Study

DiaSorin

Status: Completed

Conditions: Inflammatory Bowel Diseases

Treatments: Diagnostic Test: LIAISON Calprotectin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05168917

CLI-PR-1601

Details and patient eligibility

About

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.

Full 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)

Enrollment: 225 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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225 participants in 1 patient group

Ulcerative colitis in clinical and endoscopic remission

Other group

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.

Treatment:

Diagnostic Test: LIAISON Calprotectin