NCT05034445

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 71 (actual)
• Sponsor: Guangzhou Institute of Respiratory Disease · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

With the advancements in the development of targeted therapy, the detection of actionable genes has become routine practice in diagnosing lung cancer, especially in non-small cell lung cancer (NSCLC). Due to its non-invasiveness and great accessibility, plasma-based mutation profiling, with a sensitivity of approximately 70% relative to tissue samples, is widely used in clinical settings. Profiling using other body fluids such as pleural effusion, ascites, cerebrospinal fluid have been actively explored. Circulating cell-free DNA has also been shown to be present in other bodily fluids such as sputum and urine, which have potential to serve as liquid biopsy media for comprehensive mutation profiling. In this study, we investigated the potential of sputum obtained from NSCLC patients for mutation profiling using matched tissue, plasma and sputum from more than 30 advanced-stage NSCLC patients. Baseline tissues, plasma and sputum samples from more than 30 newly diagnosed advanced NSCLC patients with 520 Panel sequencing (tissue 1000X, sputum 1000X, plasma cfDNA 10000X), in different methods will be compared. Primary endpoints: 1、Compare different sample types with concordence rate, sensitivity, and specificity.

Conditions

• NSCLC

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Next generation sequencing	Extract DNA from sputum sample, minimum DNA amount should be over 50ng.

Timeline

• Start date: 2020-01-30
• Primary completion: 2021-04-20
• Completion: 2021-04-28
• First posted: 2021-09-05
• Last updated: 2021-09-05

Locations

1 site across 1 country: China