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

NCT06973499 | Completed DMC

• 1 other identifier: BHHMEC-XM-2022-42
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Primary Lung Cancer; Microbial Colonization

Keywords

Multiple Primary Lung Cancer; Microbiome

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Study Arms (1)

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.

Diagnostic Test: Microbiome Profiling and Symptom Assessment

Interventions

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.

Study arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Multiple primary lung cancer patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Haidian Hospital: lead

Study Sites (1)

Beijing Haidian Hospital

Beijing, China, 100080, China

Location

Related Publications (1)

• 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.

  PMID: 30733306 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Samples were collected aseptically from seven anatomical sites: Upper respiratory tract: Nasal swabs (inserted to the nasopharynx, rotated 3×, stored in RNase-free tubes at -70°C). Oral cavity: Pharyngeal swabs (8-10 s swabbing, liquid nitrogen snap-freezing). Lower respiratory tract: Bronchoalveolar lavage fluid (BALF, ≥1 mL) and protected specimen brush samples via bronchoscopy. Upper gastrointestinal (UGI) tract: Gastric fluid (≥1 mL) via gastroscopy. Lung nodules and adjacent tissues: Fresh surgical specimens (≥150 mg) rinsed with PBS, flash-frozen in liquid nitrogen.

MeSH Terms

Conditions

Communicable Diseases

Interventions

Symptom Assessment

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Yuqing Huang, M.D.

  Beijing Haidian Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 25, 2022
• First Posted: May 15, 2025
• Study Start: January 6, 2023
• Primary Completion: May 30, 2024
• Study Completion: December 25, 2024
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)