Preclinical Evaluation of Multimodal Therapeutic Strategies in Intestinal Irradiation and Inflammatory Bowel Disease From Organoids
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Validation of organoid-production method - tight junctions
研究概览
简要总结
This study is carried out in patients with IBD and healthy subjects requiring ileocolonoscopy as part of routine care (disease monitoring or polyp/colon cancer screening). It aims the generation and culturing of organoids from digestive biopsies recovered from healthy and/or pathological (inflammatory) ileal and/or colonic mucosa during an ileo-colonoscopy. These cultures will make it possible to validate the organoid production method used in the context of the research (primary objective). In a second phase (secondary objectives), the study will aim to setup a screening tool by irradiating the organoids (step one) and then evaluate in vitro the regenerative activity of treatments dedicated to improve inflammatory bowel diseases and acute radiation enteritis (step two).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •- Group 1: active IBD
- •18 years old or older
- •Assured IBD diagnosis (Crohn's disease/ulcerative colitis) according to European Crohn's and Colitis Organisation (ECCO) 2019 consensus criteria
- •Active IBD (Harvey-Bradshaw score of 4 or above for Crohn's disease or partial Mayo score of 3 or above for ulcerative colitis)
- •Indication to perform a coloscopy
- •Written consent for study participation obtained
- •- Group 2: inactive IBD
- •18 years old or older
- •Assured IBD diagnosis (Crohn's disease/ulcerative colitis) according to ECCO 2019 consensus criteria
- •Inactive IBD (Harvey-Bradshaw score below 4 for Crohn's disease or partial Mayo score below 3 for ulcerative colitis)
- •Indication to perform a coloscopy
- •Written consent for study participation obtained
- •- Group 3: Control
- •18 years old or older
- •Indication to perform a coloscopy to detect polyp
- •No known bowel disease
- •Written consent for study participation obtained
排除标准
- •Inability to understand, read, sign informed consent and/or express consent
- •Person subject to legal protection (curator, guardianship or safeguard of justice),
- •Deprivation of liberty by judicial or administrative decision,
- •Non-affiliation to a social security scheme or non-beneficiary of such a scheme
- •Pregnant, parturient, breastfeeding women
- •Contraindication to performing biopsies
- •Participation in other therapeutic research that may modify the behavior of intestinal cells (for example, drug research for the treatment of IBD)
- •Anticoagulant treatment or bleeding disorder
- •Person subject to a judicial safeguard measure
- •People hospitalized without consent
结局指标
主要结局
Validation of organoid-production method - tight junctions
时间窗: Day 1
Number of tight junctions between cells assessed by immunofluorescence
Validation of organoid-production method - quantity
时间窗: Day 1
Quantity of organoids created
Validation of organoid-production method - size
时间窗: Day 1
Size of organoids created
Validation of organoid-production method - cell growth
时间窗: Day 1
Cell-growth kinetics
Validation of organoid-production method - cell apoptosis
时间窗: Day 1
Cell-apoptosis level assessed by immunofluorescence
Validation of organoid-production method - cell composition
时间窗: Day 1
Cell composition assessed by immunofluorescence
次要结局
- Screening-tool setup - quantity(Day 1)
- Screening-tool setup - size(Day 1)
- In-vitro treatment evaluation - size(Day 1)
- Screening-tool setup - cell composition(Day 1)
- Screening-tool setup - cell apoptosis(Day 1)
- Screening-tool setup - inflammatory cytokines(Day 1)
- In-vitro treatment evaluation - quantity(Day 1)
- In-vitro treatment evaluation - cell growth(Day 1)
- Screening-tool setup - cell growth(Day 1)
- Screening-tool setup - tight junctions(Day 1)
- In-vitro treatment evaluation - cell apoptosis(Day 1)
- In-vitro treatment evaluation - inflammatory cytokines(Day 1)
- In-vitro treatment evaluation - tight junction(Day 1)
- In-vitro treatment evaluation - cell composition(Day 1)