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Completed

NCT Number: NCT05337163

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

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).

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Key information

Conditions

Lung Cancer Actinomycetales Infections Acute Bronchitis Adenocarcinoma Adenosquamous Carcinoma Bacterial Infections Bacterial Infections and Mycoses Bronchial Diseases Bronchial Neoplasms Bronchitis Bronchitis, Chronic Carcinoma Carcinoma, Adenosquamous Carcinoma, Bronchogenic Carcinoma, Large Cell Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Chronic Bronchitis Chronic Disease Chronic Obstructive Pulmonary Disease Disease Attributes Fibrosis Gram-Positive Bacterial Infections Infections Large Cell Carcinoma Lung Diseases Lung Diseases, Interstitial Lung Diseases, Obstructive Lung Neoplasm Lung Neoplasms Mycobacterium Infections Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Complex and Mixed Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Non-small Cell Lung Cancer Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pulmonary Disease, Chronic Obstructive Pulmonary Fibrosis Pulmonary Interstitial Fibrosis Respiratory Tract Diseases Respiratory Tract Infection Respiratory Tract Infections Respiratory Tract Neoplasms Sarcomatoid Carcinoma Small Cell Lung Cancer Small Cell Lung Carcinoma Squamous Cell Carcinoma Thoracic Neoplasms Tuberculosis

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanfang Hospital of Southern Medccal University

Guangzhou, Guangdong, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Diagnostic Test: Sputum DNA methylation analysis

Diagnostic Test

Diagnostic Test: sputum specimen will be collected by the subject for the detection of Human Multigene Methylation Detection Kit (Fluorescent PCR Method)

Other names: LUNSAFE

chest CT or pathological examination

Procedure

Subjects will undergo chest CT or pathological examination.

Primary outcomes

  1. Sensitivity

    Time frame: One year

    Sensitivity is the percentage of subjects with lung cancer who are correctly identified by the testing kit.

  2. Specificity

    Time frame: One year

    Specificity is the percentage of subjects without lung cancer who are correctly excluded by the testing kit.

  3. Consistency Rate

    Time frame: One year

    Consistency rate is the fraction of both true positive and negative diagnostic test results among all subjects.

  4. 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.

Sponsors and collaborators

Lead sponsor

Creative Biosciences (Guangzhou) Co., Ltd.

Industry

Collaborators

  • Guangzhou Xiangkang Medical Research Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 20, 2022
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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