NCT04214015撤回不适用
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Metastatic Mesothelioma
ProgenaBiome1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年3月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing
研究概览
简要总结
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.
详细描述
The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to Metastatic Mesothelioma
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
- •a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent
- •Male or female of all ages. (interest is given to children who present with autism or Crohn's and whose parents wish to analyze their children's gut flora. Also of interest analysis of development of the child's microbiome. In the case of autism, the younger the child, the better to correct the neurological problems if an association is found between autism and the microbiome)
- •Diagnosis of metastatic mesothelioma through biopsy and/or advanced imaging
排除标准
- •Refusal to sign informed consent form
- •History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
- •Postoperative stoma, ostomy, or ileoanal pouch
- •Participation in any experimental drug protocol within the past 12 weeks
- •Treatment with total parenteral nutrition
结局指标
主要结局
Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing
时间窗: Three years
Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized with metastatic mesothelioma
次要结局
未报告次要终点
研究者
研究点 (1)
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