Multiple Primary Lung CancerNCT06973499
Exploratory Study of the Microbiome of Upper Gastrointestinal in the Pathogenesis of Multiple Primary Lung Cancer
An observational study of Multiple Primary Lung Cancer and Microbial Colonization, run by Beijing Haidian Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Primary Lung Cancer, Microbial Colonization
- What is being tested?
- Microbiome Profiling and Symptom Assessment
- Type of treatment
- Pill or oral medicine
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2023to 25 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Multiple primary lung cancer patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Microbiome Profiling and Symptom Assessment
- Keywords
- Multiple Primary Lung Cancer, Microbiome
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiome Profiling and Symptom AssessmentDiagnostic 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Microbiome Profiling and Symptom Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Sequencing and analysis will be completed within 6 months after sample collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start6 Jan 2023
- Primary completion30 May 2024
- Study completion25 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Primary Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Haidian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huang Yuqing, Beijing Haidian Hospital
- Investigators
- Yuqing Huang, M.D., Study director, Beijing Haidian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973499
- Sponsor's protocol ID
- BHHMEC-XM-2022-42
- Status last verified
- May 2025
- First submitted
- 25 Jun 2022
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30733306
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of the Microbiome of Upper Gastrointestinal in the Pathogenesis of Multiple Primary Lung Cancer
- ClinicalTrials.gov ID
- NCT06973499
- Acronym / sponsor ID
- BHHMEC-XM-2022-42
- Keywords
- Multiple Primary Lung Cancer, Microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Beijing Haidian HospitalUniversity, hospital or other
- Study start
- 6 Jan 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 25 Dec 2024 (actual)
- First posted
- 15 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study arm | – | Diagnostic Test: Microbiome Profiling and Symptom Assessment1. 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Multiple primary lung cancer patients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microbiome Profiling and Symptom AssessmentGERD 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. | Diagnostic test | Study arm |
Primary outcome
Microbial homology between upper gastrointestinal (UGI) microbiota and intratumoral microbiota
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Background: PubMed 30733306Peters 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuqing Huang, M.D. study director
Beijing Haidian Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Primary Lung Cancer and Microbial Colonization, run by Beijing Haidian Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbial homology between upper gastrointestinal (UGI) microbiota and intratumoral microbiota (time frame: Sequencing and analysis will be completed within 6 months after sample collection.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06973499, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.