NSCLC, Stage INCT03454685
The Role of Microbiota on the Development of Lung Cancer
An observational study of NSCLC, Stage I and NSCLC, Stage II, run by Xiaorong Dong at 1 site in China.
Trial summary
Relationship between human microbiota and epidemiology of lung cancer Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- NSCLC, Stage I, NSCLC, Stage II, NSCLC, Stage III
- What is being tested?
- without intervention type
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2018to 30 Mar 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Just confirmed non-small cell lung cancer patients
Who may be able to join
- non-small cell lung cancer patients
Who cannot join
- long-term workers in the polluted environment, Patients who had used antibiotics within 1 month before sampling,
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Union hospital
Wuhan, Hubei, 430000
dong xiaorong, Dr
About this study
Relationship between human microbiota and epidemiology of lung cancer
Read the detailed description
In this study,We aim to find some kinds of human microbiota , which were associated with development of non-small cell lung cancer.
- Being tested
- without intervention type
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
without intervention typeOther
Without intervention,this study is just an observational study.
| Study group | Role | What they receive |
|---|---|---|
| NCSLC group | NSCLC patients,including stage I to stage IV. Receives: Other: without intervention type | |
| Healthy subjects | healthy subjects Receives: Other: without intervention type |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship Between Human Microbiota and Epidemiology of Lung Cancer
Find some human microbes that are associated with the development of lung cancer, we can detect these human microbiological content as a biomarker of lung cancer.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start30 Jan 2018
- Primary completion30 Jan 2020 (estimated)
- Study completion30 Mar 2020 (estimated)
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 NSCLC, Stage IStudies 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
- Case only
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaorong Dong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaorong Dong, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- dong xiaorong, Dr, Study director, china government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454685
- Sponsor's protocol ID
- 745435
- Status last verified
- May 2019
- First submitted
- 21 Jan 2018
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lu H, Gao NL, Tong F, Wang J, Li H, Zhang R, Ma H, Yang N, Zhang Y, Wang Y, Liang Z, Zeng H, Chen WH, Dong X. Alterations of the Human Lung and Gut Microbiomes in Non-Small Cell Lung Carcinomas and Distant Metastasis. Microbiol Spectr. 2021 Dec 22;9(3):e0080221. doi: 10.1128/Spectrum.00802-21. Epub 2021 Nov 17.
PubMed 34787462
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Microbiota on the Development of Lung Cancer
- ClinicalTrials.gov ID
- NCT03454685
- Acronym / sponsor ID
- 745435
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xiaorong DongUniversity, hospital or other
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 30 Jan 2020 (estimated)
- Study completion
- 30 Mar 2020 (estimated)
- First posted
- 6 Mar 2018 (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.
Relationship between human microbiota and epidemiology of lung cancer
Detailed description
In this study,We aim to find some kinds of human microbiota , which were associated with development of non-small cell lung cancer.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NCSLC group | – | Other: without intervention typeNSCLC patients,including stage I to stage IV. |
| Healthy subjects | – | Other: without intervention typehealthy subjects |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Just confirmed non-small cell lung cancer patients
Key inclusion criteria (1 listed)
- non-small cell lung cancer patients
Key exclusion criteria (1 listed)
- long-term workers in the polluted environment, Patients who had used antibiotics within 1 month before sampling,
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 |
|---|---|---|
| without intervention typeWithout intervention,this study is just an observational study. | Other | Healthy subjects, NCSLC group |
Primary outcome
Relationship Between Human Microbiota and Epidemiology of Lung Cancer
Time frame: 1 year
Find some human microbes that are associated with the development of lung cancer, we can detect these human microbiological content as a biomarker of lung cancer.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Derived from this study: PubMed 34787462Lu H, Gao NL, Tong F, Wang J, Li H, Zhang R, Ma H, Yang N, Zhang Y, Wang Y, Liang Z, Zeng H, Chen WH, Dong X. Alterations of the Human Lung and Gut Microbiomes in Non-Small Cell Lung Carcinomas and Distant Metastasis. Microbiol Spectr. 2021 Dec 22;9(3):e0080221. doi: 10.1128/Spectrum.00802-21. Epub 2021 Nov 17.
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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.
dong xiaorong, Dr study director
china government
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 NSCLC, Stage I and NSCLC, Stage II, run by Xiaorong Dong 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 1 inclusion and 1 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 4 Jun 2019. 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 dong xiaorong, Dr (15071116896, zrg27@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship Between Human Microbiota and Epidemiology of Lung Cancer (time frame: 1 year). 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 NCT03454685, 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 4 Jun 2019.