跳至主要内容
临床试验/NCT04198402
NCT04198402Unknown不适用

Microbiotic Analysis in Digestive Endocrine Tumors

Assistance Publique - Hôpitaux de Paris0 个研究点目标入组 50 人开始时间: 2020年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
主要终点
bacterial genomic signature

研究概览

简要总结

Incidence of digestive neuroendocrine tumors are increasing. Analysis of individual microbiota is a way to explore new neoplastic mechanisms, tumor identification and therapeutic orientations. This prospective pilot study aims to describe fecal bacterial phylogeny of patients with digestive neuroendocrine tumor.

Bacterial genomic signature will be recorded at initiation of Lanreotide treatment in naive patient with digestive neuroendocrine tumor (pancreas or small intestine), metastatic or locally advanced, as well as after one year follow up.

研究设计

研究类型
Observational
观察模型
Case Control
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

入选标准

  • 18 years old or older
  • naive patient with digestive neuroendocrine tumor (pancreas (cytology or histology per endoscopy or on surgical specimen) or small intestine), secreting or not, initiating a extended release Lanreotide treatment
  • registered with a social security scheme

排除标准

  • medical contraindication to somatostatine analogs use
  • history of extended release somatostatine analogs treatment
  • antibiotic use or colonoscopic purge in the last 3 weeks preceding fecal sample
  • pregnant or breastfeeding women
  • person requiring tutorship, guardianship, or person legally protected

结局指标

主要结局

bacterial genomic signature

时间窗: Baseline visit

bacterial genomic signature by fecal ARN16S analysis at enrollment

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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