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

Completed

• Conditions: Lung Neoplasm; Non-Small Cell Lung Cancer; Adenosquamous Carcinoma; Respiratory Tract Infection; Acute Bronchitis; Chronic Bronchitis; Chronic Obstructive Pulmonary Disease; Lung Cancer; Small Cell Lung Cancer; Squamous Cell Carcinoma
• Interventions: Procedure: chest CT or pathological examination

• Registration Number: NCT05337163
• Lead Sponsor: Creative Biosciences (Guangzhou) Co., Ltd.

Brief 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).

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 Timeline

• Study Start: 2022-02-25
• Study First Submitted: 2022-04-13
• Study First Submitted QC: 2022-04-13
• Study First Posted: 2022-04-20
• Status Verified: 2025-02
• Primary Completion: 2025-02-18
• Study Completion: 2025-03-05
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1564

Inclusion Criteria

• Subject must meet all three of the following criteria to be eligible for the study:

  1. No age or gender restrictions, voluntary participation and signing of informed consent form;
  2. Meet any of the following conditions:
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  1. Suspected of lung cancer without invasive examination;
  2. Diagnosed with lung cancer without surgery, radiotherapy, chemotherapy, or targeted therapy;
  3. 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;
  4. 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:

  1. Patients who have undergone tracheotomy or have been on a ventilator due to severe illness.
  2. The research physician believes that other reasons are not suitable for participants in this trial.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lung cancer group	chest CT or pathological examination	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.
The normal group	chest CT or pathological examination	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.

Primary Outcome Measures

Name	Time	Method
Sensitivity	One year	Sensitivity is the percentage of subjects with lung cancer who are correctly identified by the testing kit.
Specificity	One year	Specificity is the percentage of subjects without lung cancer who are correctly excluded by the testing kit.
Consistency Rate	One year	Consistency rate is the fraction of both true positive and negative diagnostic test results among all subjects.
Kappa Coefficient	One year	Kappa coefficient is the consistency analysis of the extent of agreement between the test results of the testing kit and standard method.

Trial Locations

Locations (1)

Nanfang Hospital of Southern Medccal University; 🇨🇳 Guangzhou, Guangdong, China