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

NCT ID: NCT06973499

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-06
• Study Completion Date: 2024-12-25

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.

Conditions

Multiple Primary Lung Cancer; Microbial Colonization

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Study arm

1. Microbial samples of oral cavity, upper and lower respiratory tract, upper digestive tract, lung lavage fluid, malignant pulmonary nodules and their adjacent sites, pathological samples and blood samples of patients with multiple primary lung cancer should be collected.

2. Blood samples were tested for T and B lymphocyte subsets, NK cell percentage and immune factors. Metagenomic sequencing (16S rDNA sequencing at malignant pulmonary nodules) was performed on the bacterial community samples from different parts, and exome and transcriptome sequencing were performed on the lesion and its adjacent tissues to obtain the genome mutation and transcriptome information of the corresponding samples.

3. In view of the above key characteristics, differentially expressed genes, pathway analysis and functional module construction were carried out to screen biologically important modules and genes related to lung cancer mutation and bacterial community microenvironment.

Microbiome Profiling and Symptom Assessment

Intervention Type: 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.

Interventions

Microbiome 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Haidian Hospital

OTHER

Sponsor Role: lead

Responsible Party

Huang Yuqing

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yuqing Huang, M.D.

Role: STUDY_DIRECTOR

Beijing Haidian Hospital

Locations

Beijing Haidian Hospital

Beijing, China, China

Countries

China

References

Peters BA, Hayes RB, Goparaju C, Reid C, Pass HI, Ahn J. The Microbiome in Lung Cancer Tissue and Recurrence-Free Survival. Cancer Epidemiol Biomarkers Prev. 2019 Apr;28(4):731-740. doi: 10.1158/1055-9965.EPI-18-0966. Epub 2019 Feb 7.

Reference Type: BACKGROUND

PMID: 30733306 (View on PubMed)

Other Identifiers

BHHMEC-XM-2022-42

Identifier Type: -

Identifier Source: org_study_id