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Completed

NCT Number: NCT06973499

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Haidian Hospital

Beijing, China, 100080

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Microbiome Profiling and Symptom Assessment

Diagnostic Test

GERD symptom assessment: Standardized GERD-Q questionnaire to evaluate reflux symptoms (heartburn, acid regurgitation) and high-risk behaviors.

Microbiome analysis: 16S rDNA sequencing of upper gastrointestinal and intratumoral microbiota.

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Beijing Haidian Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 15, 2025
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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