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NCT05337163Completed

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

A Multicenter, Single-blind, Pair-matched, Observational Clinical Trial of LUNSAFE

Source: ClinicalTrials.gov · Last updated 21 Mar 2025

Brief summary (registry, in English)

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).

Status (registry)
Completed
Study type
Observational
Enrollment
1564 (actual)
First submitted
13 Apr 2022
Start date
25 Feb 2022
Primary completion date
18 Feb 2025
Lead sponsor
Creative Biosciences (Guangzhou) Co., Ltd.
NCT number
NCT05337163

What you commit to

  • Study type: Observational
  • Participants enrolled: 1564
  • From 25 Feb 2022 to the primary completion date, 18 Feb 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Any of the following conditions must be excluded:
    • 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.

Who the study is looking for

  • Subject must meet all three of the following criteria to be eligible for the study:
    • No age or gender restrictions, voluntary participation and signing of informed consent form;
    • Meet any of the following conditions:
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    • 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.

Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Nanfang Hospital of Southern Medccal University
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.