Clinical trial · Observational
Exploratory Study of the Microbiome of Upper Gastrointestinal in the Pathogenesis of Multiple Primary Lung Cancer
NCT06973499CI-TRIAL-00089723completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Microbial Colonization | — | UNRESOLVED | — |
| Multiple Primary Lung Cancer | Malignant Neoplasm of Lung - Multiple Primary Sites | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Microbiome Profiling and Symptom Assessment | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Study arm
- description
- 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.
- interventionNames
- Diagnostic Test: Microbiome Profiling and Symptom Assessment
Primary outcomes (1)
- measure
- Microbial homology between upper gastrointestinal (UGI) microbiota and intratumoral microbiota
- timeFrame
- Sequencing and analysis will be completed within 6 months after sample collection.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDPeters 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