Clinical trial · Observational
A Multicenter Clinical Trial of Sputum DNA Testing for Lung Cancer in China
A Multicenter, Single-blind, Pair-matched, Observational Clinical Trial of LUNSAFE
NCT05337163CI-TRIAL-00087561completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (16)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Bronchitis | — | UNRESOLVED | — |
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
| Adenosquamous Carcinoma | Adenosquamous Carcinoma | ONTOLOGY_EXACT | 0.90 |
| Chronic Bronchitis | — | UNRESOLVED | — |
| Chronic Obstructive Pulmonary Disease | — | UNRESOLVED | — |
| Large Cell Carcinoma | Large Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lung Neoplasm | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Pneumonia | — | UNRESOLVED |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chest CT or pathological examination | Procedure | — | UNRESOLVED |
| Diagnostic Test: Sputum DNA methylation analysis | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 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.
- interventionNames
- Diagnostic Test: Diagnostic Test: Sputum DNA methylation analysis
- Procedure: chest CT or pathological examination
- label
- 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.
- interventionNames
- Diagnostic Test: Diagnostic Test: Sputum DNA methylation analysis
- Procedure: chest CT or pathological examination
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.