Lung CancerSTARSNCT04260295
Study of the Correlation of Tumor Tissue Microbiome to the Pathogenesis of Lung Cancer
An observational study of Lung Cancer and Microbiome, run by Huashan Hospital at 1 site in China.
Trial summary
Lung cancer is the malignant tumor with the highest incidence, accounting for the first cause of tumor death. At present, smoking, occupational and environmental exposure, air pollution and genetic factors are considered to be related to the incidence of lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer, Microbiome
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2019to 31 Jul 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subjects of this study are patients with lung shadow confirmed by CT-guided percutaneous lung biopsy. They mainly include infectious diseases of the lung, Tumors and interstitial lung diseases. The subjects are patients who cannot be diagnosed by conventional non-invasive testing methods (including blood, sputum and other specimens) and bronchoscopy, and the patients need to be diagnosed and treated as soon as possible (such as lung tumors, lung infections and other diseases ).
Who may be able to join
- Pulmonary shadow patients, including lung cancer and non-lung cancer patients, whose tissue pathology can be clearly diagnosed by percutaneous lung puncture;
- Age ≥18, ≤80 years, regardless of gender;
- Agree to submit for pathology and pathogen metagenomic sequencing;
- Voluntary signed informed consent.
Who cannot join
- Patients with metastatic lung cancer;
- Patients with contraindications to percutaneous lung puncture: those with hemorrhagic disease or severe coagulopathy; those with severe emphysema and cardiopulmonary insufficiency; the lung lesions may be vascular diseases such as hemangioma or arteriovenous fistula Etc .; severe cough cannot be controlled by uncooperatives; active hemoptysis;
- Patients with other tumorous diseases;
- patients with rheumatic diseases;
- Patients with severe primary diseases such as heart, cerebrovascular, liver, kidney, hematopoietic system;
- Patients with moderate to severe renal insufficiency (creatinine clearance ≤50ml/hour);
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- Patients with mental illness;
- Pregnancy and lactation;
- Patients who participated in other clinical trials in the past 3 months;
- Staff in the hospital and their families in this research institution.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huashan hospital,Fudan university
Shanghai, Shanghai Municipality, 200040
Shengqing Li, PhD, 02152887072, shengqingli9655@163.com
Youzhi Zhang, MD, +8602152887072, zhyouzhi1977@163.com
About this study
Official title: A Cross-sectional Study of the Correlation of Tumor Tissue Microbiome to the Pathogenesis of Lung Cancer
Lung cancer is the malignant tumor with the highest incidence, accounting for the first cause of tumor death. At present, smoking, occupational and environmental exposure, air pollution and genetic factors are considered to be related to the incidence of lung cancer. However, the occurrence of cancer is related to many factors. In recent years, researches have found that microorganisms are closely related to various human cancers. It is reported that 20% of cancers are related to multiple microorganisms, such as EB virus and nasopharyngeal cancer, HBV and liver cancer. Understanding the correlation between pathogenic microorganisms and cancer is of great significance for the pathogenesis, prevention and treatment of cancer. Basic researches have found that mycotoxins are related to animal models of lung cancer, but have not been confirmed in clinical and human.
With the help of microbial metagenome Next Generation Sequencing (mNGS) and bioinformatics analysis, the investigators initially found in clinical practice that some patients had fungal infections such as fungi in lung cancer tissues. This study intends to collect clinical cases (cross-sectional studies) to explore the correlation between the pathogenic microbiome and lung cancer, in order to confirm that the occurrence of lung cancer is closely related to microorganisms such as fungi.
Read the detailed description
The investigator designe a cross-sectional study to explore the correlation between the pathogenic microbiome and lung cancer, and to understand the specific pathogen distribution of the "lung cancer microbiome" in order to provide new ideas and strategies for the pathogenesis and prevention of lung cancer.
The subjects of this study are patients with lung shadow confirmed by CT-guided percutaneous lung biopsy. Lung shadows usually refer to high-density areas found in the parenchymal areas of the lungs on radiographs or radiographs, and often appear on CT as exudation, consolidation, masses, or nodules. Lung shadows mainly include infectious diseases of the lung, Tumors and interstitial lung diseases. The subjects are patients who cannot be diagnosed by conventional non-invasive testing methods (including blood, sputum and other specimens) and bronchoscopy, and the patients need to be diagnosed and treated as soon as possible (such as lung tumors, lung infections and other diseases ). Obtaining pathological and etiology of lung lesion tissue for examination is a necessary and effective diagnostic measure. Part of the biopsy tissue will be submitted for pathology and immunohistochemical detection, and the other part will be submitted for microbial mNGS detection.
Pulmonary shadow cases include lung cancer and non-lung cancer patients, which are intended to be included in 300 cases. According to the previous lung shadow patients admitted to respiratory department in Huashan Hospital, it is estimated that about 100 lung cancer patients and 200 non-lung cancer patients will be included, respectively.
Observation indicators in this study include histopathology of lung puncture biopsy, and next-generation sequencing of microorganisms in lung puncture biopsy.Baseline screening includes demographic data, medical history, combined medication records, symptoms, signs, electrocardiogram, lung function, and safety observation indicators. All patients will be followed up for 1 week for a total of three times, including baseline follow-up, 24 hours after lung puncture, and 1 week after lung puncture.
- Conditions
- Lung Cancer, Microbiome
- Keywords
- Microbiome, Lung Cancer
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cases of fungi found in lung cancer tissues
Number of cases of fungi found in lung cancer tissues by pathology and next-generation sequencing of microorganisms
Measured: 21 months
Number of cases of fungi found in non-lung cancer tissues
Number of cases of fungi found in non-lung cancer tissues by pathology and next-generation sequencing of microorganisms
Measured: 21 months
Secondary outcomes (2)
Number of cases of microorganisms found in lung cancer tissue
Number of cases of microorganisms found in lung cancer tissue by pathology and next-generation sequencing of microorganisms
Measured: 21 months
Number of cases of microorganisms found in non-lung cancer tissue
Number of cases of microorganisms found in non-lung cancer tissue by pathology and next-generation sequencing of microorganisms
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start1 Nov 2019
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shengqing Li, Huashan Hospital
- Investigators
- Shengqing Li, PhD, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260295
- Sponsor's protocol ID
- KY2019-128
- Acronym
- STARS
- Status last verified
- Feb 2020
- First submitted
- 5 Feb 2020
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study of the Correlation of Tumor Tissue Microbiome to the Pathogenesis of Lung Cancer
- ClinicalTrials.gov ID
- NCT04260295
- Acronym / sponsor ID
- STARS / KY2019-128
- Conditions
- Lung Cancer, Microbiome
- Keywords
- Microbiome, Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 7 Feb 2020 (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.
Lung cancer is the malignant tumor with the highest incidence, accounting for the first cause of tumor death. At present, smoking, occupational and environmental exposure, air pollution and genetic factors are considered to be related to the incidence of lung cancer. However, the occurrence of cancer is related to many factors. In recent years, researches have found that microorganisms are closely related to various human cancers. It is reported that 20% of cancers are related to multiple microorganisms, such as EB virus and nasopharyngeal cancer, HBV and liver cancer. Understanding the correlation between pathogenic microorganisms and cancer is of great significance for the pathogenesis, prevention and treatment of cancer. Basic researches have found that mycotoxins are related to animal models of lung cancer, but have not been confirmed in clinical and human.
With the help of microbial metagenome Next Generation Sequencing (mNGS) and bioinformatics analysis, the investigators initially found in clinical practice that some patients had fungal infections such as fungi in lung cancer tissues. This study intends to collect clinical cases (cross-sectional studies) to explore the correlation between the pathogenic microbiome and lung cancer, in order to confirm that the occurrence of lung cancer is closely related to microorganisms such as fungi.
Detailed description
The investigator designe a cross-sectional study to explore the correlation between the pathogenic microbiome and lung cancer, and to understand the specific pathogen distribution of the "lung cancer microbiome" in order to provide new ideas and strategies for the pathogenesis and prevention of lung cancer.
The subjects of this study are patients with lung shadow confirmed by CT-guided percutaneous lung biopsy. Lung shadows usually refer to high-density areas found in the parenchymal areas of the lungs on radiographs or radiographs, and often appear on CT as exudation, consolidation, masses, or nodules. Lung shadows mainly include infectious diseases of the lung, Tumors and interstitial lung diseases. The subjects are patients who cannot be diagnosed by conventional non-invasive testing methods (including blood, sputum and other specimens) and bronchoscopy, and the patients need to be diagnosed and treated as soon as possible (such as lung tumors, lung infections and other diseases ). Obtaining pathological and etiology of lung lesion tissue for examination is a necessary and effective diagnostic measure. Part of the biopsy tissue will be submitted for pathology and immunohistochemical detection, and the other part will be submitted for microbial mNGS detection.
Pulmonary shadow cases include lung cancer and non-lung cancer patients, which are intended to be included in 300 cases. According to the previous lung shadow patients admitted to respiratory department in Huashan Hospital, it is estimated that about 100 lung cancer patients and 200 non-lung cancer patients will be included, respectively.
Observation indicators in this study include histopathology of lung puncture biopsy, and next-generation sequencing of microorganisms in lung puncture biopsy.Baseline screening includes demographic data, medical history, combined medication records, symptoms, signs, electrocardiogram, lung function, and safety observation indicators. All patients will be followed up for 1 week for a total of three times, including baseline follow-up, 24 hours after lung puncture, and 1 week after lung puncture.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects of this study are patients with lung shadow confirmed by CT-guided percutaneous lung biopsy. They mainly include infectious diseases of the lung, Tumors and interstitial lung diseases. The subjects are patients who cannot be diagnosed by conventional non-invasive testing methods (including blood, sputum and other specimens) and bronchoscopy, and the patients need to be diagnosed and treated as soon as possible (such as lung tumors, lung infections and other diseases ).
Key inclusion criteria (4 listed)
- Pulmonary shadow patients, including lung cancer and non-lung cancer patients, whose tissue pathology can be clearly diagnosed by percutaneous lung puncture;
- Age ≥18, ≤80 years, regardless of gender;
- Agree to submit for pathology and pathogen metagenomic sequencing;
- Voluntary signed informed consent.
Key exclusion criteria (10 listed)
- Patients with metastatic lung cancer;
- Patients with contraindications to percutaneous lung puncture: those with hemorrhagic disease or severe coagulopathy; those with severe emphysema and cardiopulmonary insufficiency; the lung lesions may be vascular diseases such as hemangioma or arteriovenous fistula Etc .; severe cough cannot be controlled by uncooperatives; active hemoptysis;
- Patients with other tumorous diseases;
- patients with rheumatic diseases;
- Patients with severe primary diseases such as heart, cerebrovascular, liver, kidney, hematopoietic system;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of cases of fungi found in lung cancer tissues
Time frame: 21 months
Number of cases of fungi found in lung cancer tissues by pathology and next-generation sequencing of microorganisms
Number of cases of fungi found in non-lung cancer tissues
Time frame: 21 months
Number of cases of fungi found in non-lung cancer tissues by pathology and next-generation sequencing of microorganisms
2 secondary outcomes
Number of cases of microorganisms found in lung cancer tissue
Time frame: 21 months
Number of cases of microorganisms found in non-lung cancer tissue
Time frame: 21 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
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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.
Shengqing Li, PhD principal investigator
Huashan 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 Lung Cancer and Microbiome, run by Huashan 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 10 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: status not confirmed, as of the sponsor's last update on 7 Feb 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shengqing Li, PhD (+8602152887072, shengqingli9655@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cases of fungi found in lung cancer tissues (time frame: 21 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2020.