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临床试验/NCT06973499
NCT06973499已完成不适用

Exploratory Study of the Microbiome of Upper Gastrointestinal in the Pathogenesis of Multiple Primary Lung Cancer

Beijing Haidian Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年1月6日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Microbial homology between upper gastrointestinal (UGI) microbiota and intratumoral microbiota

研究概览

简要总结

This is an exploratory, single-center, being conducted at Beijing Haidian Hospital in order to detect the relationship between microbiome of upper gastrointestinal and pathogenesis of multiple primary lung cancer.

详细描述

This study intends to analyze the bacterial community structure of respiratory tract, upper digestive tract, lesion and adjacent to cancer in patients with multiple primary lung cancer, and to explore the association between upper digestive tract bacterial community and lung microecology, in order to find the characteristics of upper digestive tract bacterial strains involved in regulating lung cancer microenvironment, and explore the possible interaction mechanism between upper digestive tract bacterial community and lung cancer gene mutation.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • At least 18 years of age (including 18 years of age, male or female) and voluntarily signed informed consent;
  • Chest CT imaging showed at least 2 pulmonary nodules with a diameter of less than 3cm in ipsilateral lung, and imaging diagnosis of highly suspicious multiple primary lung cancer
  • No surgical contraindication, surgical resection is feasible, and postoperative pathology is diagnosed as multiple primary lung cancer according to Martini and Melamed criteria and gene testing
  • The amount of at least 2 or more tissues removed from multiple pulmonary nodules must meet the requirements of pathological diagnosis, molecular detection and microflora detection

排除标准

  • under 18 years of age (excluding 18 years of age, male or female) or unwilling to sign informed consent;
  • severe heart, liver, brain, kidney and other important organ diseases and bone marrow hematopoietic dysfunction;
  • Preoperative examination of patients who cannot tolerate surgical resection
  • Patients who received antibiotics within 1 week before surgery E) Resected multiple pulmonary nodules with pathologically proven lung cancer of less than 2 patients
  • Multiple nodules resected were confirmed to be metastases, not primary lung cancer

结局指标

主要结局

Microbial homology between upper gastrointestinal (UGI) microbiota and intratumoral microbiota

时间窗: Sequencing and analysis will be completed within 6 months after sample collection.

Based on 16S rDNA sequencing data, calculate the Bray-Curtis similarity index between the intratumoral microbiota and the patient's own upper gastrointestinal (UGI) microbiota. Use SourceTracker2 to quantify the contribution of UGI microbiota to the intratumoral microbiota. Apply PERMANOVA analysis to compare the differences in microbiota similarity between the MPLC and SPLC groups.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Huang Yuqing

Director

Beijing Haidian Hospital

研究点 (1)

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