Loading clinical trials...
Loading clinical trials...
EURECA (EUropeanRElapseCAlprotectin) Study - Calprotectin as Prediction Marker of Relapse in Patients With Quiescent Ulcerative Colitis
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)
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
June 2, 2017
Primary Completion Date
January 13, 2020
Completion Date
January 13, 2020
Last Updated
January 6, 2022
225
ACTUAL participants
LIAISON Calprotectin
DIAGNOSTIC_TEST
Lead Sponsor
DiaSorin Inc.
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06579443