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

NCT05337163 | Completed

• 1 other identifier: KLM2021-02
• Study Type: observational
• Target: 1,564
• Locations: 1 country
• Sites: 1

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).

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

Keywords

Lung Cancer; Sputum DNA Test; Gene Methylation Biomarkers; Multigene Methylation Detection; Cancer Screening

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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: 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.

Diagnostic Test: Diagnostic Test: Sputum DNA methylation analysis; Procedure: chest CT or pathological examination

Interventions

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)

Also known as: LUNSAFE

Lung cancer group; The normal group

chest CT or pathological examination PROCEDURE

Subjects will undergo chest CT or pathological examination.

Lung cancer group; The normal group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Creative Biosciences (Guangzhou) Co., Ltd.: lead
• Guangzhou Xiangkang Medical Research Co., Ltd.: collaborator

Study Sites (1)

Nanfang Hospital of Southern Medccal University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Lung Neoplasms; Small Cell Lung Carcinoma; Carcinoma, Non-Small-Cell Lung; Carcinoma, Squamous Cell; Adenocarcinoma; Carcinoma, Large Cell; Carcinoma, Adenosquamous; Carcinoma; Respiratory Tract Infections; Bronchitis; Pneumonia; Bronchitis, Chronic; Pulmonary Disease, Chronic Obstructive; Tuberculosis; Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Neoplasms, Complex and Mixed; Infections; Bronchial Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Lung Diseases, Interstitial; Fibrosis

Study Officials

• Lei Zheng, PhD

  Nanfang Hospital of Southern Medccal University

  PRINCIPAL INVESTIGATOR

• Laiyu Liu, PhD

  Nanfang Hospital of Southern Medccal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 20, 2022
• Study Start: February 25, 2022
• Primary Completion: February 18, 2025
• Study Completion: March 5, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-02

Locations

CN (1)