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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06973499
Enrollment
20
Registered
2025-05-15
Start date
2023-01-06
Completion date
2024-12-25
Last updated
2025-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microbial Colonization, Multiple Primary Lung Cancer

Keywords

Multiple Primary Lung Cancer, Microbiome

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.

Interventions

DIAGNOSTIC_TESTMicrobiome Profiling and Symptom Assessment

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.

Sponsors

Beijing Haidian Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Microbial homology between upper gastrointestinal (UGI) microbiota and intratumoral microbiotaSequencing 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026