Clinical trial · Observational
Whether Sputum Can Serve as an Alternative Source for Liquid Biopsy in Patients With Lung Cancer
A Prospective Study of Advanced NSCLC Patients Genomic Landscape Through Sputum NGS Detection
- 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)
This study intends to use Onconscreen plus 520 Panel (Burning Rock, China) to conduct NGS testing in sputum, tissues and blood samples of patients with advanced NSCLC. In order to explore the use of sputum as a diagnosis method for NSCLC patients, we will collect relevant clinical information and follow-up treatment information. The primary endpoint will reveal the effectiveness, accuracy, and feasibility in sputum, as compared to tissues and blood samples. This study aims to study the feasibility and advantages/disadvantages of using sputum as an noval body fluid biopsy option.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Next generation sequencing | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Sputum group
- description
- Sputum samples from more than 30 newly diagnosed advanced NSCLC patients with 520 Panel sequencing (sputum 1000X)
- interventionNames
- Diagnostic Test: Next generation sequencing
- label
- Tissue group
- description
- Clinical data review to obtain corresponding tissue samples from more than 30 newly diagnosed advanced NSCLC patients with 520 Panel sequencing (tissue 1000X)
- label
- Plasma group
- description
- Clinical data review to obtain corresponding plasma samples from more than 30 newly diagnosed advanced NSCLC patients with 520 Panel sequencing (plasma 10000X)
Primary outcomes (1)
- measure
- Compare different sample types with concordence rate, sensitivity, and specificity.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with stage IIIB-IV NSCLC in AJCC TNM stage (8th edition) confirmed with histology or cytology; 2. Newly diagnosed; 3. There are sufficient samples that meet the requirements for examination; 4. Eligible for the next anti-tumor systemic treatment; 5. Willing to sign the consent inform, age ≥18 years; 6. Patients willing to cooperate with the planned follow-up schedule; 7. Permit to collect clinical data needed by the institute. Exclusion Criteria: 1. Diagnosed with other malignant tumors at the same time (except for fully treated cervical carcinoma in situ, basal or squamous cell skin cancer); 2. The patient has other serious diseases that may affect follow-up and short-term survival; 3. Any other medical conditions and social/psychological problems that investigator evaluated is not suitable to enroll in this study; 4. Absents of contrast-enhanced magnetic resonance imaging (MRI) or contrast-enhanced computer tomography (CT) during clinical follow-up.
References
Publications (0)
Data not yet available