Genomic/Epigenomic Biomarkers of Deregulation of Immune System in Inflammatory Bowel Diseases: Prediction of Post-operating Natural History of Crohn's Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- Gene expression profile in intestinal operative specimens
研究概览
简要总结
The purpose is to search for enterocyte-specific or non-specific molecular signature of post-operating recurrence of Crohn's disease in transcriptome (measurement of gene expression through number of mRNA copies transcribed for each gene) and in methylome.
Secondary objectives are to compare expression and methylation profiles according to:
- treatment response
- morphological (endoscopic and/or radiological) and clinical post-operating recurrence.
详细描述
This aim of this study is to search for new biomarkers predictive of post-operating recurrence.
At present, there are no biomarkers predictive for post-operating recurrence and administration of a post-operating medical treatment to prevent recurrence is based on biological, endoscopic and imagery data.
Predictive biomarkers could allow the identification of patients with high risk of post-operating recurrence and administration of a systematic prophylactic post-operating treatment and at the same time avoiding the prescription of this treatment to patients with low risk of post-operating recurrence.
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
- •Patient with inflammatory bowel disease diagnosis based on clinical (abdominal pain, diarrhea and/or dysenteric syndrome, mostly muco-hemorrhagic, perianal injury, with sometimes general signs and /or systemic manifestations ), biological (inflammatory syndrome, deficiencies...), radiological (entero-MRI), endoscopic (presence of granulomatous lesions) and/or histological (epithelioid and giant cellular granuloma) data
- •Patient undergoing ileocolic resection
- •Patient affiliated to French social security
排除标准
- •Patient refusing sampling
- •Patient with undetermined colitis
- •Patient with non-confirmed diagnosis of inflammatory bowel disease
- •Patient with inflammatory bowel disease not undergoing ileocolic resection
结局指标
主要结局
Gene expression profile in intestinal operative specimens
时间窗: up to 2 months (from resection)
Methylation profile in intestinal operative specimens
时间窗: up to 2 months (from resection)
次要结局
- Digestive symptoms(6, 12, 24 months (after resection))
- Radiological classification of recurrence with entero-MRI performed for post-operating follow-up of patients(6, 12, 24 months (after resection))
- Evaluation of recurrence with endoscopy performed for post-operating follow-up of patients(6, 12, 24 months (after resection))