Clinical trial NCT05337163: A Multicenter Clinical Trial of Sputum DNA Testing for Lung Cancer in China
Official title: A Multicenter, Single-blind, Pair-matched, Observational Clinical Trial of LUNSAFE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Small Cell Lung Cancer
Non-Small Cell Lung Cancer
Squamous Cell Carcinoma
Adenocarcinoma
Large Cell Carcinoma
Adenosquamous Carcinoma
Sarcomatoid Carcinoma
Respiratory Tract Infection
Acute Bronchitis
Pneumonia
Chronic Bronchitis
Chronic Obstructive Pulmonary Disease
Tuberculosis
Lung Neoplasm
Pulmonary Interstitial Fibrosis
Keywords: Lung Cancer
Sputum DNA Test
Gene Methylation Biomarkers
Multigene Methylation Detection
Cancer Screening
Lead sponsor: Creative Biosciences (Guangzhou) Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Guangzhou Xiangkang Medical Research Co., Ltd.
First posted: 2022-04-20
Enrollment: 1564
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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:

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  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.

Primary outcomes:
measure: Sensitivity
timeFrame: One year
measure: Specificity
timeFrame: One year
measure: Consistency Rate
timeFrame: One year
measure: Kappa Coefficient
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medccal University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital of Southern Medccal University
name: Lei Zheng, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanfang Hospital of Southern Medccal University
name: Laiyu Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References: