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

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

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).

Study Overview

• Status: Completed
• Conditions: Pneumonia; Adenocarcinoma; Small Cell Lung Cancer; Chronic Obstructive Pulmonary Disease; Non-Small Cell Lung Cancer; Lung Cancer; Tuberculosis; Chronic Bronchitis; Squamous Cell Carcinoma; Lung Neoplasm; Respiratory Tract Infection; Acute Bronchitis; Adenosquamous Carcinoma; Large Cell Carcinoma; Sarcomatoid Carcinoma; Pulmonary Interstitial Fibrosis
• Intervention / Treatment: Diagnostic test: Diagnostic Test: Sputum DNA methylation analysis; Procedure: chest CT 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 Type: Observational
• Enrollment (Actual): 659

Contacts and Locations

• Study Contact: Name: Xianshu Wang, PhD; Phone Number: 86-01-18819269978; Email: xianshuwang@creativebio.cn
• Study Contact Backup: Name: Chunhua Chen; Phone Number: 86-01-13560141654; Email: chenchunhua@creativebio.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Nanfang Hospital of Southern Medccal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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. 492 subjects are targeted to enroll.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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; Procedure: chest CT or pathological examination; 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: 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); Other Names: LUNSAFE; Procedure: chest CT or pathological examination; Subjects will undergo chest CT or pathological examination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Creative Biosciences (Guangzhou) Co., Ltd.
• Collaborators: Guangzhou Xiangkang Medical Research Co., Ltd.
• Investigators: Principal Investigator: Lei Zheng, PhD, Nanfang Hospital of Southern Medccal University; Principal Investigator: Laiyu Liu, PhD, Nanfang Hospital of Southern Medccal University

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2022
• Primary Completion (Actual): May 6, 2023
• Study Completion (Actual): August 29, 2023

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: April 13, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Lung Cancer; Cancer Screening; Sputum DNA Test; Gene Methylation Biomarkers; Multigene Methylation Detection
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Disease Attributes; Bronchial Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Fibrosis; Neoplasms, Complex and Mixed; Mycobacterium Infections; Lung Diseases, Interstitial; Chronic Disease; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Lung Neoplasms; Carcinoma; Pulmonary Fibrosis; Tuberculosis; Small Cell Lung Carcinoma; Respiratory Tract Infections; Carcinoma, Adenosquamous; Bronchitis; Bronchitis, Chronic; Carcinoma, Large Cell
• Other Study ID Numbers: KLM2021-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

Undecided

We are carefully considering all applicable regulations and laws governing sharing of patients' data from China online with the global public.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No