Characteristics of the Intestinal Microbiota in Patients With Cancer (Catalogue-Onco)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 4
- 主要终点
- Microbial DNA
研究概览
简要总结
In order to understand how the intestinal microbiota plays a role in the effectiveness of an anti-cancer treatment by an immune control point inhibitor, this study aims to constitute a catalog of microbial genes of a patient with cancer. This catalog will help to characterize the intestinal microbiota of cancer patients and to be able to use this catalog as a reference tool for screening the microbiota of patients treated with immune control point inhibitors. To produce this catalog, five types of cancer were selected: non-small cell lung cancer, colorectal cancer, hepatocellular carcinoma, breast cancer and prostate cancer.
The metagenomic analysis of a group of five different types of cancers introduces a lot of heterogeneity which is favorable to the richness of a catalog. For non-small cell lung cancer treated with immune control point inhibitors, two stool collections will be performed per patient (one stool collection before setting up an immune control point inhibitor and one collection after one month of being inhibited Of immune control point) to assess the impact of the immune control point inhibitor on the microbiota (pilot study). For this study, two stool collection tubes containing different preservative solutions will be used (one RNAlater tube and one DMSO-EDTA tube for Dimethylsulfoxide-Ethylene diamine tetraacetic acid).
In parallel, we will also collect samples of serum and plasma to evaluate, in a second step, protein markers in circulating blood.
详细描述
Primary objective: Develop a catalog of microbial genes dedicated to oncology (Onco catalog) by sequencing stool specimens from patients with cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women between 18 and 75 years of age.
- •Patients with one of the following types of cancer: non-small cell lung cancer, hepatocellular carcinoma, colorectal cancer, breast cancer, prostate cancer and glioblastoma
- •Patients with informed consent to participate in the study.
- •Affiliation to the social security system
排除标准
- •For patients with hepatocellular cancer, patients infected with the human immunodeficiency virus (HIV)
- •Patients who are unable to understand, read and / or sign informed consent
- •Patients who can not collect / send stools for geographical, social or psychological reasons
- •Patients with previous cancer in the 5 years preceding this study
- •Persons benefiting from a system of protection for adults (including guardianship and curatorship)
- •Pregnant or nursing women
- •Patients with another synchronous tumor
- •Patients with fecal transplant
- •Patients with chronic inflammatory bowel disease (IBD)
- •Patients having had in the 3 months preceding the collection of stool: colonoscopy, bariatric surgery, surgical removal of a segment of the small intestine (enteritomy or enterostomy), parenteral nutrition.
- •Patients who had had antibiotic therapy within 1 month before stool collection
结局指标
主要结局
Microbial DNA
时间窗: inclusion
Bio-computer and bio-statistical analyzes will be carried out in order to constitute the gene catalog.
次要结局
未报告次要终点