Prospective Study of the Natural History, Immunological and Genetic Characteristics of Preclinical Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 450
- 试验地点
- 25
- 主要终点
- Omic findings
研究概览
简要总结
The purpose of this study is to evaluate disease progression, in terms of development of symptomatic disease and complications associated with IBD (e.g. fistula, abscess, stricture).
详细描述
This is a prospective, observational, multicenter, collaborative research project that will explore the earlier stages of IBD, before the onset of the first symptoms of the disease. This novel approach constitutes an innovative strategy on the research on the natural history of the disease. The study will be carried out based on colorectal cancer screening colonoscopies, recruiting all patients with a new diagnosis of IBD in this setting. These patients will undergo follow-up visits every 6 months for 10 years and the clinical information will be enriched with longitudinal multi-omic analyses.
Two additional control groups will be identified, including patients with new-onset symptomatic IBD in the last 3 months and healthy controls (with normal screening colonoscopy).
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
- 是
入选标准
- •Patients from cohort A will be included if they fulfill all the following inclusion criteria:
- •Male or female ≥18 years of age at baseline.
- •New diagnosis of IBD during a CRC screening colonoscopy, based on the criteria from the European Crohn's and Colitis Organization (33, 34).
- •Presence of a chronic inflammatory infiltrate and histological diagnosis compatible with IBD.
- •The patient must be asymptomatic at diagnosis and without previous symptoms suggestive of IBD.
- •Time interval between the index colonoscopy and the baseline visit up to 3 months.
- •Patients from cohort B will be included if they fulfill all the following inclusion criteria:
- •Male or female ≥18 years of age at baseline.
- •Recent diagnosis of IBD, with <3 months from symptoms onset.
- •Time interval between the index colonoscopy and the baseline visit up to 3 months.
- •Patients from cohort C will be included if they fulfill all the following inclusion criteria:
- •Male or female ≥18 years of age at baseline.
- •No endoscopic signs of IBD after a complete ileo-colonoscopy within the CRC screening program.
- •Time interval between the index colonoscopy and the baseline visit up to 3 months.
排除标准
- •Patients from cohort A will be excluded if they fulfill any the following exclusion criteria:
- •Identification of any enteropathogen in the stool culture.
- •Isolated findings of acute inflammatory infiltrate without signs of chronicity.
- •Previous or current diagnosis of microscopic colitis.
- •Alteration in biomarkers in blood or stool will not constitute an exclusion criterion.
- •Patients from cohort B will be excluded if they fulfill any the following exclusion criteria:
- •- Previous use of immunomodulators or biologics for any condition.
- •Patients from cohort C will be excluded if they fulfill any the following exclusion criteria:
- •Any gastrointestinal symptoms at baseline.
- •Previous use of immunomodulators or biologics for any condition.
研究组 & 干预措施
Cohort A (preclinical IBD)
asymptomatic patients with a new diagnosis of IBD during the colorectal cancer screening programme meeting all inclusion and none of the exclusion criteria (n=350).
干预措施: bioespecimen samples (Procedure)
Cohort B (control)
new-onset symptomatic IBD (n=80) - patients with a symptomatic debut of IBD in the last 3 months, naïve to immunosuppressants and biologic agents.
干预措施: bioespecimen samples (Procedure)
Cohort C (control)
healthy controls (n=20): patients with a normal screening colonoscopy, with no signs of IBD after a detailed evaluation of the ileum and colon, will be included.
干预措施: bioespecimen samples (Procedure)
结局指标
主要结局
Omic findings
时间窗: 10 years
proteomic, transcriptomic, serologic, microbiota, and tissue data
- IBD characteristics
时间窗: 10 years
* Type (CD or UC) * Disease extent (CD or UC) according to Montreal classification * CD phenotype at diagnosis (Montreal classification) * Endoscopic characteristics at diagnosis (both CD and UC): type of lesions, distribution, and extent * Presence and type (simple, complex fistula or abscess) of perianal disease at diagnosis and during follow-up
Disease progression
时间窗: 10 years
Development and type of new-onset symptoms during follow-up (mainly diarrhea, abdominal pain, and rectal bleeding).
次要结局
- Development and time to development of need for medical or surgical therapy during follow-up(10years)
- Type of extraintestinal manifestations during follow-up(10years)
- IBD characteristics:(10 years)
- Microscopic characteristics at diagnosis(10 years)
- Changes in endoscopic features during follow-up(10 years)
- Clinical disease activity during follow-up(10years)
- Development and time to development of extraintestinal manifestations during follow-up(10years)