Prospective and Multicenter Study About the Epidemiology and the Characteristics "Omics" in Patients Recently Diagnosed of Inflammatory Bowel Disease in Spain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 376
- 试验地点
- 16
- 主要终点
- Incidence of IBD in Spain
研究概览
简要总结
This is a prospective, observational, multicenter, population-based incidence cohort study which will enroll cases of inflammatory bowel disease IBD (Crohn´s disease CD, ulcerative colitis UC, or indeterminate colitis) diagnosed in adults over 18 months in Spain.
In addition, each incident case that gave his/her informed consent, will be followed up for 12 months to determine changes in phenotype or disease location, the need for immunosuppressive and biologic treatments, and the need for hospital admissions and surgery during the first year after diagnosis.
Also, samples of of blood, urine and stool will be collected during the first year after diagnosis
详细描述
STUDY DESIGN This is a prospective, observational, multicenter, population-based incidence cohort study which will enroll cases of IBD (CD, UC, or indeterminate colitis) diagnosed in adults over 18 months in Spain.
In addition, each incident case that gave his/her informed consent, will be followed up for 12 months to determine changes in phenotype or disease location, the need for immunosuppressive and biologic treatments, and the need for hospital admissions and surgery during the first year after diagnosis.
Samples of blood, urine and stool will be collected during the study visits.
To achieve the aims this study will be Split in two studies.
- Epidemiology study to achieve aims 1 and 2.
- Characterization "omics" study to achieve aims 3, 4 and 5.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male or female ≥18 years of age diagnosed of inflammatory bowel disease
- •Diagnosis of IBD according to European Crohns and Colitis Organisation (ECCO) criteria.
- •The patient must belong to the health area of one of the participating center
- •Patients who have accepted to participate in the epidemiology study
- •< 1 month since the date of the diagnosis colonoscopy
排除标准
- •Patients who do not belong to the health area of the participating centers
- •Patients who do not accept to participate in the study
- •Patients who have initiated a treatment to IBD
- •Patients who received a immunomodulators to treat other disease
- •Patients with a immune-mediates systemic disease
- •Patients with a active infection or a malignancy in the baseline
- •Pregnant patients or breastfeeding
结局指标
主要结局
Incidence of IBD in Spain
时间窗: 1 year
Measure the incidence of IBD in Spain
次要结局
- Characteristics of patients at diagnosis of inflammatory bowel disease and resources used in the first year after diagnosis(1 year)
- Create a wide collection of samples(1 year)
- Correlate the serum proteomic profile and the density(1 year)
- Identify the molecular and cellular pathways involved with IBD development and pathogenesis.(1 year)