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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05337163
• Other study ID #: KLM2021-02
• Status: Completed
• Start date: February 25, 2022
• Est. completion date: August 29, 2023

Study information

• Verified date: August 2023
• Source: Creative Biosciences (Guangzhou) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 659
• Est. completion date: August 29, 2023
• Est. primary completion date: May 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

1. Who without age and gender limit, and is participating voluntarily and willing to sign Informed Consent Form;

2. Who is willing to undergo or has completed chest CT and / or pathological examination within 3 months prior to enrollment;

3. 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.

4. Any subject who is required to meet any of the following conditions:

1. Who is diagnosed with or suspected of lung cancer, but without surgery, chemoradiotherapy, or targeted therapy;

2. 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;

3. 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.;

4. Who has chronic cough with duration=8 weeks;

5. Who has other interfering diseases, such as oral cancer, thyroid cancer, etc.

Exclusion Criteria:

• Subject with any of the following conditions shall be excluded:

1. Who has a tracheotomy or has been seriously ill and already on a ventilator.

2. Who has other conditions that the investigator considers inappropriate to participate in this clinical trial.

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• 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)

Procedure:
• chest CT or pathological examination
Subjects will undergo chest CT or pathological examination.

Locations

Country	Name	City	State
China	Nanfang Hospital of Southern Medccal University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Creative Biosciences (Guangzhou) Co., Ltd.	Guangzhou Xiangkang Medical Research Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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