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.
- Diseases
- Tuberculosis, COPD, Lung cancer, Childhood cancers
- 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:
- <!-- -->
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanfang Hospital of Southern Medccal University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.