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临床试验/NCT07082231
NCT07082231尚未招募不适用

Cohort of Patients With Ulcerative Colitis or Polyps Followed in CHU de Bordeaux Associated With a Biocollection - COLIBRI

University Hospital, Bordeaux2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
200
试验地点
2
主要终点
UCEIS endoscopic activity score

研究概览

简要总结

Ulcerative colitis (UC) is a chronic disease characterized by acute episodes of bloody diarrhea with varying degrees of severity. The most feared event, acute severe UC, can lead to life-threatening and systemic complications. Little is known about the determinants of severity in UC. The investigators hypothesize that distinct severity phenotypes of UC arise from intricated host-microbiota mechanisms influencing repair mechanisms. Our first and main objective is to study the natural history of UC during a one-year time period in a cohort of patients.

详细描述

Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by acute episodes of varying-severity bloody diarrhea. Acute severe colitis poses systemic risks. In our pilot ITAC project, the investigators found a direct link between deep colonic ulcers and systemic inflammation in acute severe colitis, suggesting repair failure. Conversely, excessive repair in UC can lead to colorectal neoplasia, especially sessile serrated adenomas in remission cases.. The investigators plan to prospectively collect tissue and blood samples of patients with UC or non-UC patients with polyps undergoing endoscopy in the Gastroenterology unit or colectomy in the Abdominal surgery unit of CHU de Bordeaux. For all patients, additional biopsies will be collected for histology, microbiota characterization, transcriptomic profiling and cells phenotyping. Additional blood samples will be collected for immune cells phenotyping, genetic profiling, and multiplex cytokines measurement. Routine clinical, endoscopic and biological data will be collected using the Entrepot de Données de Santé of CHU de Bordeaux. The patients will be divided in groups based on the endoscopy phenotype: unactive disease, non-severe active disease, severe disease and on the presence of polyps. Patients without ulcerative colitis with polyps will be studied as a control group.clinical, endoscopic and biological data will be collected using the Entrepot de Données de Santé of CHU de Bordeaux. The patients will be divided in groups based on the endoscopy phenotype: unactive disease, non-severe active disease, severe disease and on the presence of polyps. Patients without ulcerative colitis with polyps will be studied as a control group.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
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

入选标准

  • Inclusion criteria:
  • General Inclusion Criteria:
  • Patients covered by a social security system.
  • French-speaking patients.
  • Patients aged ≥18 years.
  • Patients who have provided free, informed, and written consent (no later than the inclusion day and before any research-related examination).
  • Specific Inclusion Criteria for the UC Group:
  • Patients diagnosed with ulcerative colitis (UC) according to the European Crohn's and Colitis Organisation (ECCO) guidelines.
  • Patients undergoing lower gastrointestinal endoscopy or rectocolic surgery.
  • Non-UC Patients with Polyps Group:
  • Patients undergoing colonoscopy with resection of hyperplastic polyps in the rectum, sessile serrated lesions, or adenomas >2 cm.

排除标准

  • Patients with perianal, ileal lesions, or endoscopic features of colonic lesions suggestive of Crohn's disease.
  • Pregnant or breastfeeding women.
  • Patients under legal protection or unable to provide informed consent.
  • Patients deprived of liberty by judicial or administrative decision, hospitalized without consent, or admitted to a healthcare or social institution for reasons unrelated to the study.

结局指标

主要结局

UCEIS endoscopic activity score

时间窗: Baseline, Month 12

Evolution of UCEIS endoscopic activity score between inclusion and last visit. There is 3 items. Each item is rated from 0 to 2 or 0 to 3 and total score that varies from 0 to 8

Nancy histological activity score

时间窗: Baseline, Month 12

Evolution of Nancy histological activity score between inclusion and last visit. The Nancy index is defined by a 5-level classification ranging from grade 0 (absence of significant histological disease activity) to grade 4 (severely active disease).

Advanced therapy (biologics or small molecules)

时间窗: Baseline, Month 12

Number of new advanced therapy (biologics or small molecules) between inclusion visit and last visit

Mayo clinical activity score

时间窗: Baseline, Month 12

Evolution of Mayo clinical activity score between inclusion and last visit. There is 4 items and for each item is rated from 0 to 3 and total score that varies from 0 to 12

Hospitalization due to disease flare

时间窗: Baseline, Month 12

Number of hospitalization due to disease flare between inclusion visit and last visit

Colectomy

时间窗: Baseline, Month 12

Number of colectomy between inclusion and last visit

次要结局

未报告次要终点

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (2)

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