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

March 18, 2025 updated by: Creative Biosciences (Guangzhou) Co., Ltd.

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

Intervention / Treatment

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)

1564

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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.

Description

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:
    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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

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
Time Frame: One year
Sensitivity is the percentage of subjects with lung cancer who are correctly identified by the testing kit.
One year
Specificity
Time Frame: One year
Specificity is the percentage of subjects without lung cancer who are correctly excluded by the testing kit.
One year
Consistency Rate
Time Frame: One year
Consistency rate is the fraction of both true positive and negative diagnostic test results among all subjects.
One year
Kappa Coefficient
Time Frame: One year
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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2022

Primary Completion (Actual)

February 18, 2025

Study Completion (Actual)

March 5, 2025

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)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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