Inflammatory Bowel Diseases
Conditions
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)
Interventions
DIAGNOSTIC_TESTLIAISON Calprotectin
Immunoassay for fecal calprotectin measurement
Sponsors
DiaSorin Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Basal visit and follow up visits at 3,9,and 18 months in which stool specimens wil be collected.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Sensitivity and 95% Confidence Interval (exact method) | Through study completion, an average of 36 months | Computed and compared to the clinical diagnosis |
| Clinical Specificity and 95% Confidence Interval (exact method) | Through study completion, an average of 36 months | Computed and compared to the clinical diagnosis |
| Positive Predictive Value and 95% Confidence Interval (exact method) | Through study completion, an average of 36 months | Computed and compared to the clinical diagnosis |
| Kaplan-Meier survival curve | Through study complete, an average of 36 months | 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
| Measure | Time frame | Description |
|---|---|---|
| ROC Analysis and the relevant plots | Through study completion, an average of 36 months | Analysis will determine if the assay was assigned with appropriate cut-off value |
Countries
France, Italy, Spain
Outcome results
None listed