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

Sponsor
Creative Biosciences (Guangzhou) Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05337163
Collaborator
Guangzhou Xiangkang Medical Research Co., Ltd. (Other)
492
1
8.1
60.6

Study Details

Study Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
492 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
A Multicenter, Single-blind, Pair-matched, Observational Clinical Trial of LUNSAFE
Actual Study Start Date :
Feb 25, 2022
Anticipated Primary Completion Date :
Jul 25, 2022
Anticipated Study Completion Date :
Oct 30, 2022

Arms and Interventions

Arm 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.

    Outcome Measures

    Primary Outcome Measures

    1. Sensitivity [One year]

      Sensitivity is the percentage of subjects with lung cancer who are correctly identified by the testing kit.

    2. Specificity [One year]

      Specificity is the percentage of subjects without lung cancer who are correctly excluded by the testing kit.

    3. Consistency Rate [One year]

      Consistency rate is the fraction of both true positive and negative diagnostic test results among all subjects.

    4. Kappa Coefficient [One year]

      Kappa coefficient is the consistency analysis of the extent of agreement between the test results of the testing kit and standard method.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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:

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

    6. 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;

    7. 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.;

    8. Who has chronic cough with duration≥8 weeks;

    9. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nanfang Hospital of Southern Medccal University Guangzhou Guangdong China

    Sponsors and Collaborators

    • Creative Biosciences (Guangzhou) Co., Ltd.
    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Creative Biosciences (Guangzhou) Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT05337163
    Other Study ID Numbers:
    • KLM2021-02
    First Posted:
    Apr 20, 2022
    Last Update Posted:
    Apr 20, 2022
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Creative Biosciences (Guangzhou) Co., Ltd.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 20, 2022