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

Creative Biosciences

Status: Completed

Conditions: Acute Bronchitis; Squamous Cell Carcinoma; Pulmonary Interstitial Fibrosis; Respiratory Tract Infection; Small Cell Lung Cancer; Lung Cancer; Lung Neoplasm; Adenocarcinoma; Non-Small Cell Lung Cancer; Adenosquamous Carcinoma; Chronic Bronchitis; Tuberculosis; Chronic Obstructive Pulmonary Disease; Sarcomatoid Carcinoma; Pneumonia; Large Cell Carcinoma

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

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05337163

KLM2021-02

Details and patient eligibility

About

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).

Full 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.

Enrollment: 659 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

659 participants in 2 patient groups

Lung cancer group

Description:

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.

Treatment:

Diagnostic Test: Diagnostic Test: Sputum DNA methylation analysis

Procedure: chest CT or pathological examination

The normal group

Description:

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.

Treatment:

Diagnostic Test: Diagnostic Test: Sputum DNA methylation analysis

Procedure: chest CT or pathological examination