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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LIAISON Calprotectin | Diagnostic Test | Immunoassay for fecal calprotectin measurement |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alberto Malesci, Professor | Istituto Clinico Humanitas, Head of Gastroenterology Department | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire De Nancy (CHU de Nancy) Department Gastroenterology | Nancy | France | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35789124 | Derived | 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 18, 2022 | Feb 10, 2022 | 2 | ||
| Feb 16, 2022 |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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Basal visit and follow up visits at 3,9,and 18 months in which stool specimens wil be collected.
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| Istituto Clinico Humanitas Centro IBD Diparimento di Gastroenterologia |
| Milan |
| Italy |
| Centro Médico Teknon Gastroenterologia Adultos | Barcelona | Spain |
| Mar 17, 2022 |
| 3 |