EURECA (EUropeanRElapseCAlprotectin) Study - Calprotectin as Prediction Marker of Relapse in Patients With Quiescent Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 225
- 试验地点
- 3
- 主要终点
- Positive Predictive Value and 95% Confidence Interval (exact method)
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Positive Predictive Value and 95% Confidence Interval (exact method)
时间窗: Through study completion, an average of 36 months
Computed and compared to the clinical diagnosis
Clinical Sensitivity and 95% Confidence Interval (exact method)
时间窗: Through study completion, an average of 36 months
Computed and compared to the clinical diagnosis
Kaplan-Meier survival curve
时间窗: 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.
Clinical Specificity and 95% Confidence Interval (exact method)
时间窗: Through study completion, an average of 36 months
Computed and compared to the clinical diagnosis
次要结局
- ROC Analysis and the relevant plots(Through study completion, an average of 36 months)