A Multicenter Clinical Trial of Sputum DNA Testing for Lung Cancer in China

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multicenter, Single-blind, Pair-matched, Observational Clinical Trial of LUNSAFE

Conditions
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Lung Cancer, Small Cell Lung Cancer, Non-Small Cell Lung Cancer, Squamous Cell Carcinoma, Adenocarcinoma, Large Cell Carcinoma, Adenosquamous Carcinoma, Sarcomatoid Carcinoma, Respiratory Tract Infection, Acute Bronchitis, Pneumonia, Chronic Bronchitis, Chronic Obstructive Pulmonary Disease, Tuberculosis, Lung Neoplasm, Pulmonary Interstitial Fibrosis

Intervention / Treatment
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* Diagnostic Test: Diagnostic Test: Sputum DNA methylation analysis
* Procedure: chest CT or pathological examination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must meet all three of the following criteria to be eligible for the study: Who without age and gender limit, and is participating voluntarily and willing to sign Informed Consent Form; Who is willing to undergo or has completed chest CT and / or pathological examination within 3 months prior to enrollment; Any subject who is current or former smoker with a history of smoking at least 30 packs per year, who has a history of smoking less than 15 years, and who has no history of pulmonary nodules or lung cancer. Any subject who is required to meet any of the following conditions: Who is diagnosed with or suspected of lung cancer, but without surgery, chemoradiotherapy, or targeted therapy; Who has a history of smoking with at least 30 packs per year, and has quit smoking for less than 15 years, and has no history of pulmonary nodules or lung cancer; Who has a long history of second-hand smoking or environmental lampblack inhalation, or a history of carcinogenic exposure in the workplace, or a history of tumors, or a family history of lung cancer in their immediate relatives, etc.; Who has chronic cough with duration≥8 weeks; Who has other interfering diseases, such as oral cancer, thyroid cancer, etc. Exclusion Criteria: Subject with any of the following conditions shall be excluded: Who has a tracheotomy or has been seriously ill and already on a ventilator. Who has other conditions that the investigator considers inappropriate to participate in this clinical trial.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lung cancer group<br>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. | Diagnostic Test: Diagnostic Test: Sputum DNA methylation analysis<br>* Diagnostic Test: sputum specimen will be collected by the subject for the detection of Human Multigene Methylation Detection Kit (Fluorescent PCR Method)<br>* Other names: LUNSAFE;Procedure: chest CT or pathological examination<br>* Subjects will undergo chest CT or pathological examination.<br>|
| The normal group<br>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. | Diagnostic Test: Diagnostic Test: Sputum DNA methylation analysis<br>* Diagnostic Test: sputum specimen will be collected by the subject for the detection of Human Multigene Methylation Detection Kit (Fluorescent PCR Method)<br>* Other names: LUNSAFE;Procedure: chest CT or pathological examination<br>* Subjects will undergo chest CT or pathological examination.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | Sensitivity is the percentage of subjects with lung cancer who are correctly identified by the testing kit. | One year | 
| Specificity | Specificity is the percentage of subjects without lung cancer who are correctly excluded by the testing kit. | One year | 
| Consistency Rate | Consistency rate is the fraction of both true positive and negative diagnostic test results among all subjects. | 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. | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Cancer, Sputum DNA Test, Gene Methylation Biomarkers, Multigene Methylation Detection, Cancer Screening