CompletedNot Applicable

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

China1,564 participantsStarted 2022-02-25

Plain-language 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).

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. No age or gender restrictions, voluntary participation and signing of informed consent form;
✓. Meet any of the following conditions:
✓. Suspected of lung cancer without invasive examination;
✓. Diagnosed with lung cancer without surgery, radiotherapy, chemotherapy, or targeted therapy;
✓. 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;
✓. Diagnose other malignant tumors, such as thyroid cancer, esophageal cancer, liver cancer, gastric cancer, pancreatic cancer, etc.

Exclusion criteria

✕. Patients who have undergone tracheotomy or have been on a ventilator due to severe illness.
✕. The research physician believes that other reasons are not suitable for participants in this trial.

What they're measuring

Sensitivity

Timeframe: One year

Specificity

Timeframe: One year

Consistency Rate

Timeframe: One year

Kappa Coefficient

Timeframe: One year

Trial details

NCT IDNCT05337163

SponsorCreative Biosciences (Guangzhou) Co., Ltd.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-02-18

View on ClinicalTrials.gov More Lung Cancer trials

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. No age or gender restrictions, voluntary participation and signing of informed consent form;
✓. Meet any of the following conditions:
✓. Suspected of lung cancer without invasive examination;
✓. Diagnosed with lung cancer without surgery, radiotherapy, chemotherapy, or targeted therapy;
✓. 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;
✓. Diagnose other malignant tumors, such as thyroid cancer, esophageal cancer, liver cancer, gastric cancer, pancreatic cancer, etc.

Exclusion criteria

✕. Patients who have undergone tracheotomy or have been on a ventilator due to severe illness.
✕. The research physician believes that other reasons are not suitable for participants in this trial.