Lung CancerNCT05337163
A Multicenter Clinical Trial of Sputum DNA Testing for Lung Cancer in China
An observational study of Lung Cancer and Small Cell Lung Cancer, run by Creative Biosciences (Guangzhou) Co., Ltd. at 1 site in China.
Trial summary
The primary objective of this study is to assess the safety and effectiveness of Human Multigene Methylation Detection Kit (Fluorescent PCR Method) for help diagnose lung cancer by comparing with clinical standard method (includes chest CT examination or pathological examination). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Small Cell Lung Cancer, Non-Small Cell Lung Cancer
- What is being tested?
- Diagnostic Test: Sputum DNA methylation analysis and chest CT or pathological examination
- Type of treatment
- Surgery or procedure
- How many people
- 1,564 participants
- Where
- 1 siteChina
- Study dates
- 25 Feb 2022to 5 Mar 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Subjects without age limit, regardless of gender or region, and those who meet the inclusion criteria for this clinical trial, are eligible to enroll at the designated clinical sites.
Who may be able to join
- Subject must meet all three of the following criteria to be eligible for the study:
- No age or gender restrictions, voluntary participation and signing of informed consent form;
- Meet any of the following conditions:
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- Suspected of lung cancer without invasive examination;
- Diagnosed with lung cancer without surgery, radiotherapy, chemotherapy, or targeted therapy;
- Diagnose other respiratory diseases, such as pulmonary infections (bacterial pneumonia, mycoplasma pneumonia, chlamydia pneumonia, viral pneumonia, lung abscess, etc.), interstitial lung diseases (pulmonary fibrosis, pulmonary granulomas, etc.), benign pulmonary nodules, tuberculosis, emphysema, pulmonary cysts, benign pulmonary tumors, obstructive pulmonary disease, bronchial infections/asthma, acute upper respiratory tract infections, etc;
- Diagnose other malignant tumors, such as thyroid cancer, esophageal cancer, liver cancer, gastric cancer, pancreatic cancer, etc.
Who cannot join
- Any of the following conditions must be excluded:
- Patients who have undergone tracheotomy or have been on a ventilator due to severe illness.
- The research physician believes that other reasons are not suitable for participants in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Nanfang Hospital of Southern Medccal University
Guangzhou, Guangdong
About this study
Official title: A Multicenter, Single-blind, Pair-matched, Observational Clinical Trial of LUNSAFE
The primary objective of this study is to assess the safety and effectiveness of Human Multigene Methylation Detection Kit (Fluorescent PCR Method) for help diagnose lung cancer by comparing with clinical standard method (includes chest CT examination or pathological examination).
Read the detailed description
In this clinical trial, the testing kit to be evaluated is a Human Multigene Methylation Detection Kit (Fluorescent PCR Method), which is intended to qualitatively detect methylation levels of multiple genes in human sputum specimen in vitro by Fluorescent PCR Method, and the standard method used in clinical diagnosis is chest CT examination or pathological examination.
Subjects will provided sputum specimen as required for the evaluation of the testing kit followed by a chest CT examination or pathological examination. Technical personnel who conduct the evaluation of the testing kit will remain blinded to the results of the clinical diagnosis by chest CT and/or pathological examination.
The results of the testing kit will be compared with the standard method, and the effectiveness of the Human Multigene Methylation Detection Kit (Fluorescent PCR Method) for lung cancer detection under normal clinical use will be assessed through statistical analysis.
- Conditions
- Lung Cancer, Small Cell Lung Cancer, Non-Small Cell Lung Cancer, Squamous Cell Carcinoma, Adenocarcinoma, Large Cell Carcinoma
- Being tested
- Diagnostic Test: Sputum DNA methylation analysis, chest CT or pathological examination
- Keywords
- Lung Cancer, Sputum DNA Test, Gene Methylation Biomarkers, Multigene Methylation Detection, Cancer Screening
- Medical subject headings
- Lung Neoplasms, Small Cell Lung Carcinoma, Carcinoma, Non-Small-Cell Lung, Carcinoma, Squamous Cell, Adenocarcinoma, Carcinoma, Large Cell, Carcinoma, Adenosquamous, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Test: Sputum DNA methylation analysisDiagnostic test
Also called LUNSAFE
Diagnostic Test: sputum specimen will be collected by the subject for the detection of Human Multigene Methylation Detection Kit (Fluorescent PCR Method)
chest CT or pathological examinationProcedure or surgery
Subjects will undergo chest CT or pathological examination.
| Study group | Role | What they receive |
|---|---|---|
| Lung cancer group | Two groups of sequential enrolled subjects, eligible subjects will be included in the study according to the inclusion criteria. In addition to collecting sputum specimen for the testing kit of Human Multigene Methylation Detection Kit (Fluorescent PCR Method) , eligible subjects also need to undergo the chest CT or pathological examination. Receives: Diagnostic Test: Diagnostic Test: Sputum DNA methylation analysis; Procedure: chest CT or pathological examination | |
| The normal group | Two groups of sequential enrolled subjects, eligible subjects will be included in the study according to the inclusion criteria. In addition to collecting sputum specimen for the testing kit of Human Multigene Methylation Detection Kit (Fluorescent PCR Method) , eligible subjects also need to undergo the chest CT or pathological examination. Receives: Diagnostic Test: Diagnostic Test: Sputum DNA methylation analysis; Procedure: chest CT or pathological examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Sensitivity is the percentage of subjects with lung cancer who are correctly identified by the testing kit.
Measured: One year
Specificity
Specificity is the percentage of subjects without lung cancer who are correctly excluded by the testing kit.
Measured: One year
Consistency Rate
Consistency rate is the fraction of both true positive and negative diagnostic test results among all subjects.
Measured: One year
Kappa Coefficient
Kappa coefficient is the consistency analysis of the extent of agreement between the test results of the testing kit and standard method.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start25 Feb 2022
- Primary completion18 Feb 2025
- Study completion5 Mar 2025
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.
- 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
- Retrospective
- Enrolment
- 1,564 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creative Biosciences (Guangzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guangzhou Xiangkang Medical Research Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Lei Zheng, PhD, Principal investigator, Nanfang Hospital of Southern Medccal UniversityLaiyu Liu, PhD, Principal investigator, Nanfang Hospital of Southern Medccal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337163
- Sponsor's protocol ID
- KLM2021-02
- Status last verified
- Feb 2025
- First submitted
- 13 Apr 2022
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided We are carefully considering all applicable regulations and laws governing sharing of patients' data from China online with the global public.
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-blind, Pair-matched, Observational Clinical Trial of LUNSAFE
- ClinicalTrials.gov ID
- NCT05337163
- Acronym / sponsor ID
- KLM2021-02
- Conditions
- Lung Cancer, Small Cell Lung Cancer, Non-Small Cell Lung Cancer, Squamous Cell Carcinoma, Adenocarcinoma, Large Cell Carcinoma
- Keywords
- Lung Cancer, Sputum DNA Test, Gene Methylation Biomarkers, Multigene Methylation Detection, Cancer Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,564 participants (actual)
- Lead sponsor
- Creative Biosciences (Guangzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Guangzhou Xiangkang Medical Research Co., Ltd.
- Study start
- 25 Feb 2022 (actual)
- Primary completion
- 18 Feb 2025 (actual)
- Study completion
- 5 Mar 2025 (actual)
- First posted
- 20 Apr 2022 (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.
The primary objective of this study is to assess the safety and effectiveness of Human Multigene Methylation Detection Kit (Fluorescent PCR Method) for help diagnose lung cancer by comparing with clinical standard method (includes chest CT examination or pathological examination).
Detailed description
In this clinical trial, the testing kit to be evaluated is a Human Multigene Methylation Detection Kit (Fluorescent PCR Method), which is intended to qualitatively detect methylation levels of multiple genes in human sputum specimen in vitro by Fluorescent PCR Method, and the standard method used in clinical diagnosis is chest CT examination or pathological examination.
Subjects will provided sputum specimen as required for the evaluation of the testing kit followed by a chest CT examination or pathological examination. Technical personnel who conduct the evaluation of the testing kit will remain blinded to the results of the clinical diagnosis by chest CT and/or pathological examination.
The results of the testing kit will be compared with the standard method, and the effectiveness of the Human Multigene Methylation Detection Kit (Fluorescent PCR Method) for lung cancer detection under normal clinical use will be assessed through statistical analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung cancer group | – | Diagnostic Test: Diagnostic Test: Sputum DNA methylation analysis, Procedure: chest CT or pathological examinationTwo groups of sequential enrolled subjects, eligible subjects will be included in the study according to the inclusion criteria. In addition to collecting sputum specimen for the testing kit of Human Multigene Methylation Detection Kit (Fluorescent PCR Method) , eligible subjects also need to undergo the chest CT or pathological examination. |
| The normal group | – | Diagnostic Test: Diagnostic Test: Sputum DNA methylation analysis, Procedure: chest CT or pathological examinationTwo groups of sequential enrolled subjects, eligible subjects will be included in the study according to the inclusion criteria. In addition to collecting sputum specimen for the testing kit of Human Multigene Methylation Detection Kit (Fluorescent PCR Method) , eligible subjects also need to undergo the chest CT or pathological examination. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects without age limit, regardless of gender or region, and those who meet the inclusion criteria for this clinical trial, are eligible to enroll at the designated clinical sites.
Key inclusion criteria (8 listed)
- Subject must meet all three of the following criteria to be eligible for the study:
- <!-- -->
Key exclusion criteria (3 listed)
- Any of the following conditions must be excluded:
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 |
|---|---|---|
| Diagnostic Test: Sputum DNA methylation analysisAlso: LUNSAFEDiagnostic Test: sputum specimen will be collected by the subject for the detection of Human Multigene Methylation Detection Kit (Fluorescent PCR Method) | Diagnostic test | Lung cancer group, The normal group |
| chest CT or pathological examinationSubjects will undergo chest CT or pathological examination. | Procedure or surgery | Lung cancer group, The normal group |
Primary outcome
Sensitivity
Time frame: One year
Sensitivity is the percentage of subjects with lung cancer who are correctly identified by the testing kit.
Specificity
Time frame: One year
Specificity is the percentage of subjects without lung cancer who are correctly excluded by the testing kit.
Consistency Rate
Time frame: One year
Consistency rate is the fraction of both true positive and negative diagnostic test results among all subjects.
Kappa Coefficient
Time frame: One year
Kappa coefficient is the consistency analysis of the extent of agreement between the test results of the testing kit and standard method.
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 21 Mar 2025.
- Individual participant dataSharing planned: Undecided. Undecided We are carefully considering all applicable regulations and laws governing sharing of patients' data from China online with the global public.
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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.
Lei Zheng, PhD principal investigator
Nanfang Hospital of Southern Medccal University
Laiyu Liu, PhD principal investigator
Nanfang Hospital of Southern Medccal University
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 Small Cell Lung Cancer, run by Creative Biosciences (Guangzhou) Co., Ltd. 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 8 inclusion and 3 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 21 Mar 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?
Sensitivity (time frame: One year). The study lists 4 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 21 Mar 2025.