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

Completed

• Conditions: Multiple Primary Lung Cancer; Microbial Colonization

• Registration Number: NCT06973499
• Lead Sponsor: Beijing Haidian Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-06-25
• Study Start: 2023-01-06
• Primary Completion: 2024-05-30
• Study Completion: 2024-12-25
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-07
• Last Update Submitted: 2025-05-07
• Study First Posted: 2025-05-15
• Last Update Posted: 2025-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. At least 18 years of age (including 18 years of age, male or female) and voluntarily signed informed consent;
2. 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
3. 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
4. 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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Microbial homology between upper gastrointestinal (UGI) microbiota and intratumoral microbiota	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.

Trial Locations

Locations (1)

Beijing Haidian Hospital; 🇨🇳 Beijing, China