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: 1,564 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. 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.

Trial design

1,564 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:

Procedure: chest CT or pathological examination

Diagnostic Test: Diagnostic Test: Sputum DNA methylation analysis

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:

Procedure: chest CT or pathological examination

Diagnostic Test: Diagnostic Test: Sputum DNA methylation analysis