NCT04198402Unknown不适用
Microbiotic Analysis in Digestive Endocrine Tumors
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
- 否
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
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