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

NCT ID: NCT05337163

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1564 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-25
• Study Completion Date: 2025-03-05

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Diagnostic Test: Sputum DNA methylation analysis

Intervention Type: DIAGNOSTIC_TEST

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 examination

Intervention Type: PROCEDURE

Subjects will undergo 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.

Diagnostic Test: Sputum DNA methylation analysis

Intervention Type: DIAGNOSTIC_TEST

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 examination

Intervention Type: PROCEDURE

Subjects will undergo chest CT or pathological examination.

Interventions

Diagnostic Test: Sputum DNA methylation analysis

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

Intervention Type: DIAGNOSTIC_TEST

chest CT or pathological examination

Subjects will undergo chest CT or pathological examination.

Intervention Type: PROCEDURE

Other Intervention Names

LUNSAFE

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guangzhou Xiangkang Medical Research Co., Ltd.

UNKNOWN

Sponsor Role: collaborator

Creative Biosciences (Guangzhou) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lei Zheng, PhD

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital of Southern Medccal University

Laiyu Liu, PhD

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital of Southern Medccal University

Locations

Nanfang Hospital of Southern Medccal University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

KLM2021-02

Identifier Type: -

Identifier Source: org_study_id